Recall Z-1263-03 ยท KDC Instrument, Surgical, Disposable
International Surgical Supply, Inc.
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a:
| Date | Sep 23, 2003 (initiated Sep 3, 2003) |
| Status | Terminated |
| Reason | Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed. |
| Root cause | Other |
| Action | The firm sent an e-mail recall notification and request for response on 9/3/2003, to the one direct account in Minnesota requesting quarantine and return of product and also subrecall down to the hospital/health professional level. |
| Quantity | 36 |
| Distribution | Product was distributed to a direct consignee/distributor in Minnesota and also directly to the only two hospital/health professional accounts involved both in Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.