Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14… — Class II medical device recall Z-0949-2021
Terminated recall by Riverpoint Medical, LLC, reported 2021-02-10, distributed in NJ. Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This
| Recall number | Z-0949-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Riverpoint Medical, LLC, Portland, OR, United States |
| Recall initiated | 2020-12-09 |
| Classified | 2021-02-03 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2023-04-21 |
| Distributed | NJ |
| Countries outside the US | DE, ES, HR, IN, IT, PL |
| Quantity | 3,060 units |
| Reason classes | potency, device malfunction |
| UPC / GTIN / UDI-DI | 10884521151307 |
| Lot numbers | 19062715X |
Product
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Reason for recall
Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
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-0949-2021. 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.