Recall Z-0067-06 ยท GWG Endoscope, Neurological
Remington Medical Inc.
Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized.
| Date | Oct 21, 2005 (initiated Jun 6, 2005) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1500 units |
| Distribution | AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.