Recall Z-1856-2008 ยท GDG Hook, Surgical, General & Plastic Surgery
Telefelx Medical
Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only.
| Date | Sep 4, 2008 (initiated May 12, 2008) |
| Status | Terminated |
| Reason | The bands are breaking within the sealed packaging or in use prior to the expiration dates. |
| Root cause | Incorrect or no expiration date |
| Action | Consignees were notified by letter via UPS next day, on/about 05/12/2008. They were instructed to return all affected product or acknowledge that the product no longer exists. They were further instructed to forward the letter to if they have further distributed the affected lots into institutional settings or to homecare patients and retrieve relevant product from those locations. If you require additional information or clarification regarding this matter, please contact Jackie Warner at 1-800-334-9751, ext. 4973. |
| Quantity | 5763 units |
| Distribution | U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K771187 | DERMAHOOK #382-805 Edward Weck, Inc., Jul 11, 1977 |