Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture — Class II medical device recall Z-1558-2014
Terminated recall by Teleflex Medical, reported 2014-05-14, distributed in AL, CA, FL, GA, IL, IN, KS, LA…. Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached fr
| Recall number | Z-1558-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2014-03-11 |
| Classified | 2014-05-06 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2017-08-14 |
| Distributed | 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 |
| Countries outside the US | CA, DE, IE |
| Quantity | 32,271 units |
| Reason classes | potency, device malfunction |
| Lot numbers | 02A1003137, 02D1101137, 02F1103013, 02H1302839, 02J1101705 |
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 for recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1558-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.