Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 We
FDA device recall Z-1857-2008 · posted 2008-09-04 · Terminated
Recall details
- Recalling firm
- Telefelx Medical
- Reason for recall
- The bands are breaking within the sealed packaging or in use prior to the expiration dates.
- Action taken
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- GDG
- Quantity affected
- 8492 units
- Distribution
- U.S., Argentina, Australia, Brazil, Canada, Costa Rica, France, Mexico, Puerto Rico, Singapore, and the Virgin Islands
- Date initiated
- 2008-05-12
- Date posted
- 2008-09-04
- Date terminated
- 2012-04-19
- Location
- Durham, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DERMAHOOK #382-805 (K771187) | Edward Weck, Inc. | 1977-07-11 |