Recall Z-0393-05 ยท GDO Applier, Surgical, Clip
Weck
Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.
| Date | Jan 13, 2005 (initiated Oct 31, 2001) |
| Status | Terminated |
| Reason | The flush port on some appliers was occluded with an epoxy resin during manufacturing. |
| Root cause | Other |
| Action | Consignees were notified by letter on 10/31/2001. |
| Quantity | 66 units |
| Distribution | AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.