Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-
FDA device recall Z-1497-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The products are being recalled because they did not meet minimum diameter requirements.
- Action taken
- Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected constomers. The letter identified the affected product, problem and actions to be taken. Customers were instructed if they have affected stock immediately discontinue use, quarantine, and return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgement Form and Fax it to 1-508-964-6078, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-508-964-6042.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAQ
- Quantity affected
- 3,816 ea
- Distribution
- Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.
- Date initiated
- 2014-03-11
- Date posted
- 2014-04-24
- Date terminated
- 2015-12-17
- 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 |
|---|---|---|
| SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (K930738) | Deknatel, Inc. | 1994-07-26 |