PlainRecordsFDA · Medical device recall
Remington Medical… and 2 more products
- Date posted by the FDA
- Oct. 21, 2005
- Status
- Terminated
- Filed by
- Remington Medical Inc.
- Reason
- The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
- Distribution pattern
- AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI
3 products in this recall
Remington Medical…
- Product
- Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.
- Quantity
- 3180 units
- Codes and lots
- Lot No. 040508, 041111, 042116, 042367, 043146, 050077, 041464
- Recall started
- June 6, 2005
- Device type
- Endoscope, Neurological
- Root cause (FDA)
- Other
- What the company told customers
- A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter.
- Recall number
- Z-0065-06
Remington Medical…
- Product
- Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile: Single Use/Disposable Radiopague Contents Ethylene Oxide Sterilized
- Quantity
- 1500 units
- Codes and lots
- Lot No. 043003, 042674, 042313
- Recall started
- June 6, 2005
- Device type
- Endoscope, Neurological
- Root cause (FDA)
- Other
- What the company told customers
- A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter.
- Recall number
- Z-0066-06
Remington Medical…
- Product
- Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized.
- Quantity
- 1500 units
- Codes and lots
- Lot No. 041603, 041731, 050201, 050274
- Recall started
- June 6, 2005
- Device type
- Endoscope, Neurological
- Root cause (FDA)
- Other
- What the company told customers
- A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter.
- Recall number
- Z-0067-06
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0065-06, Z-0066-06, Z-0067-06. The agency record governs; check it and the company before acting.