FDA Device recall Z-1559-2014
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico
- FDA Device
- Class II
- terminated
- Published 2014-05-14
On 2014-05-14 the FDA classified a Class II recall of Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico 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-1559-2014 |
| 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
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. 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 H5300 - Lot 1450153E13 |
|---|
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-1559-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.