Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephth
FDA device recall Z-1292-2014 · posted 2014-03-26 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The products are being recalled because they did not meet minimum needle attachment strength requirements.
- Action taken
- Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GAT
- Quantity affected
- Total 32,271 ea.
- Distribution
- Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
- Date initiated
- 2014-03-11
- Date posted
- 2014-03-26
- Date terminated
- 2017-08-15
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (K021019) | Genzyme Corp. | 2002-06-18 |