Monodek Violet Synthetic Absorbable Surgical Sutures — Class II medical device recall Z-1509-2014
Terminated recall by Teleflex Medical, reported 2014-04-30. Product does not meet minimum knot tensile strength requirements.
| Recall number | Z-1509-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2014-03-11 |
| Classified | 2014-04-24 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2017-09-25 |
| Countries outside the US | DE |
| Quantity | 3,072 units |
| Reason classes | potency |
| Lot numbers | 02H1103434, 02H1200349, 02K1201354 |
Product
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Reason for recall
Product does not meet minimum knot tensile strength requirements.
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-1509-2014. 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.