FDA · Medical device recall

Breast Pack… and 50 more products

July 15, 2015 Class II

Date: July 15, 2015
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Completed
Filed by: Stradis Healthcare, LLC.
Reason: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Distribution pattern: Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

51 products in this recall

Breast Pack…

Product: Breast Pack - contains Devon Light Glove Used during surgery
Quantity: 9
Codes and lots: Pack 693-196, 693-188, 693-166, 693-112, 888-2583
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1992-2015

Basic Pack…

Product: Basic Pack - contains Devon Light Glove Used during surgery
Quantity: 6
Codes and lots: Pack 693-203, 888-2375, 888-2396, 888-2430, 888-2495, 888-2594
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1993-2015

Advanced Vein Care…

Product: Advanced Vein Care - contains Devon Light Glove Used during surgery
Quantity: Two
Codes and lots: Pack 682-956
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1994-2015

Vein Pack…

Product: Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery
Quantity: 55
Codes and lots: Pack 682-949, 682-937, 682-900, 682-370, 682-218, 682-1264, 682-1529, 682-076, 682-192, 682-962, 682-968, 682-177, 682-394, 682-988, 682-156, 682-063, 682-151, 682-917, 682-250, 682-409, 682-960, 682-945, 682-218, 682-1264, 682-1412, 682-1422
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1995-2015

Endovenous Kit…

Product: Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
Quantity: 15
Codes and lots: Pack 682-156, 682-1548, 682-931, 682-493, 682-263, 682-931, 682-1419, 682-493, 682-044
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1996-2015

Phleb Pack and Laser Phleb Pack…

Product: Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
Quantity: 9
Codes and lots: Pack 682-1284, 682-299, 682-410, 682-353, 682-377, 682-548
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1997-2015

Standard Pack…

Product: Standard Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 681-022A
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1998-2015

Lipo Pack…

Product: Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
Quantity: 13
Codes and lots: Pack 681-025, 681-268, 681-254, 681-013, 681-506, 888-2587
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-1999-2015

Lipo/Buttocks Pack…

Product: Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 681-256
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2000-2015

Vaginal Rejuvenation Pack…

Product: Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 693-222
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2001-2015

General Pack…

Product: General Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 670-115
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2002-2015

Vein & Vascular Pack…

Product: Vein & Vascular Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 682-670
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2003-2015

Laser Evlt Pack and Laser One Leg Evlt…

Product: Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery
Quantity: 3
Codes and lots: Pack 682-670, 682-501, 682-547
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2004-2015

Breast Augmentation Pack and Breast Augmentation Expanded Pack…

Product: Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery
Quantity: 24
Codes and lots: Pack 681-502, 693-177, 681-243, 681-502, 681-502, 693-158, 682-502, 681-503
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2005-2015

Tummy Tuck Pack…

Product: Tummy Tuck Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 693-223
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2006-2015

Surgical Pack and General Surgery Pack…

Product: Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery
Quantity: 4
Codes and lots: Pack 40604EBS, 693-152, 40759MMS, 888-2371
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2007-2015

Mississippi Pack…

Product: Mississippi Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 682-1302
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2008-2015

Face Lift Pack…

Product: Face Lift Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 693-102
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2009-2015

Plastic Pack and Plastic HNP Pack…

Product: Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
Quantity: 5
Codes and lots: Pack 693-210, 693-054, 693-219, 888-2479, 888-2499
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2010-2015

Suction Pack…

Product: Suction Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 670-057
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2011-2015

ACL Pack…

Product: ACL Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 693-055
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2012-2015

Hand Pack…

Product: Hand Pack - contains Devon Light Glove Used during surgery
Quantity: 3
Codes and lots: Pack 693-057, 888-2345, 888-2596
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2013-2015

Lima Pack…

Product: Lima Pack - contains Devon Light Glove Used during surgery
Quantity: 2
Codes and lots: Pack 682-927
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2014-2015

Skin and Vein Pack…

Product: Skin and Vein Pack - contains Devon Light Glove Used during surgery
Quantity: 3
Codes and lots: Pack 682-1218
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2015-2015

Vasc Custom Kit…

Product: Vasc Custom Kit - contains Devon Light Glove Used during surgery
Quantity: 3
Codes and lots: Pack 682-126
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2016-2015

Bariatric Pack…

Product: Bariatric Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 682-678
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2017-2015

Face Neck Pack…

Product: Face Neck Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 693-167
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2018-2015

Abdominal Pack and Abdom Pack…

Product: Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery
Quantity: 2
Codes and lots: Pack 670-056, 681-014
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2019-2015

Stradi 4500…

Product: Stradi 4500 - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 682-1102
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2020-2015

Gyn Pack…

Product: Gyn Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 693-111
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2021-2015

Head & Neck Pack…

Product: Head & Neck Pack - contains Devon Light Glove Used during surgery
Quantity: 2
Codes and lots: Pack 681-012, 888-2385
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2022-2015

Eye Pack…

Product: Eye Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 687-191
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2023-2015

Glaucoma Pack…

Product: Glaucoma Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 687-395
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2024-2015

Shoulder Pack…

Product: Shoulder Pack - contains Devon Light Glove Used during surgery
Quantity: One
Codes and lots: Pack 888-2349
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2025-2015

Knee Arthro Pack and Knee Arthro Pack II…

Product: Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
Quantity: 3
Codes and lots: Pack 888-2359, 888-2531, 888-2351
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2026-2015

ENT Pack…

Product: ENT Pack - contains Devon Light Glove Used during surgery
Quantity: 2
Codes and lots: Pack 888-2352, 888-2434
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2027-2015

Hand Pack…

Product: Hand Pack - contains Devon Light Glove Used during surgery
Quantity: 4
Codes and lots: Pack 888-2376, 888-2397, 888-2414, 888-2471
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2028-2015

Podiatry Pack…

Product: Podiatry Pack - contains Devon Light Glove Used during surgery
Quantity: 4
Codes and lots: Pack 888-2378, 888-2411, 888-2429, 888-2553
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2029-2015

Minor Pack and Minor Pack II Pack…

Product: Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery
Quantity: 2
Codes and lots: Pack 888-2381, 888-2541
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2030-2015

Neurosurgery Pack…

Product: Neurosurgery Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2489
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2031-2015

Cysto Pack…

Product: Cysto Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2492
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2032-2015

Open Pack…

Product: Open Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2493
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2033-2015

Pediatric Pack…

Product: Pediatric Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2494
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2034-2015

Face Lift Pack…

Product: Face Lift Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2532
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2035-2015

Set Up Pack…

Product: Set Up Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2546
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2036-2015

Blepharoplasty Pack…

Product: Blepharoplasty Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2533
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2037-2015

Custom Pack…

Product: Custom Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2552
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2038-2015

DND Pack…

Product: DND Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2595
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2039-2015

Orthopedic Split Drape Pack…

Product: Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2604
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2040-2015

Arthroscopy Pack…

Product: Arthroscopy Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2605
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2041-2015

Upper Extremity Pack…

Product: Upper Extremity Pack - contains Devon Light Glove Used during surgery
Quantity: 1
Codes and lots: Pack 888-2606
Recall started: April 20, 2015
Device type: General Surgery Tray
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.
Recall number: Z-2042-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1992-2015, Z-1993-2015, Z-1994-2015, Z-1995-2015, Z-1996-2015, Z-1997-2015, Z-1998-2015, Z-1999-2015 and others. The agency record governs; check it and the company before acting.

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