FDA Device recall Z-1558-2014
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Me…
- FDA Device
- Class II
- terminated
- Published 2014-05-14
On 2014-05-14 the FDA classified a Class II recall of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Me… by Teleflex Medical, citing product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1558-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-11 |
| Published | 2014-05-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | AL, CA, FL, GA, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI, WV |
Product
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
Reason
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Identifiers
| code_info | Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1558-2014%22
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