FDA · Medical device recall

Applied Medical's Direct Drive Laparoscopic Clip Applier… and 18 more products

March 3, 2011

Date posted by the FDA: March 3, 2011
Status: Terminated
Filed by: Applied Medical Resources Corp
Reason: Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage.
Distribution pattern: Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

19 products in this recall

Applied Medical's Direct Drive Laparoscopic Clip Applier…

Product: Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1118775, 1118776, 1118777, 1119556, 1119558,1119559, 1119565, 1119566, 1119567
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1499-2011

Applied Medical's GELPOINT LAP CHOLE KIT 2…

Product: Applied Medical's GELPOINT LAP CHOLE KIT 2; Model Number: CK102 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Codes and lots: LOT NUMBER(S): 1120791
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1500-2011

Applied Medical's LAP CHOLE KIT 5 GK…

Product: Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1122206
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1501-2011

Applied Medical's LAP CHOLE KIT 7 GK…

Product: Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121985
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1502-2011

Applied Medical's LAP CHOLE KIT 8 GK…

Product: Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121907
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1503-2011

Applied Medical's LAP CHOLE KIT 9 GK…

Product: Applied Medical's LAP CHOLE KIT 9 GK; Model Number: GK109-H The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121687
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1504-2011

Applied Medical's LAP CHOLE KIT 16 GK…

Product: Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121989
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1505-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT ; Model Number: K0491 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121822
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1506-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT ; Model Number: K0492 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121504, 1122116
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1507-2011

Applied Medical's AM CHOLE KIT-TAM1…

Product: Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121903
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1508-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121811
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1509-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121587
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1510-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT ; Model Number: K0630 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1122117
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1511-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT ; Model Number: K0684 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1122194
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1512-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT ; Model Number: K2114 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121706
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1513-2011

Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT…

Product: Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121401
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1514-2011

Applied Medical's LAP CHOLE KIT…

Product: Applied Medical's LAP CHOLE KIT; Model Number: K2154 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121612, 1121974, 1121863, 1122208
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1515-2011

Applied Medical's LAP CHOLE…

Product: Applied Medical's LAP CHOLE ; Model Number: K2155 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121372
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1516-2011

Applied Medical's KW/MOH LAP CHOLE KIT…

Product: Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Quantity: 2,843 units for all products
Codes and lots: LOT NUMBER(S): 1121545, 1121972, 1121973, 1121962, 1122267
Recall started: Sept. 10, 2010
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.
Recall number: Z-1517-2011

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1499-2011, Z-1500-2011, Z-1501-2011, Z-1502-2011, Z-1503-2011, Z-1504-2011, Z-1505-2011, Z-1506-2011 and others. The agency record governs; check it and the company before acting.

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