Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed… — Class II medical device recall Z-0019-2021
Terminated recall by Riverpoint Medical, LLC, reported 2020-10-07, distributed nationwide. The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site i
| Recall number | Z-0019-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Riverpoint Medical, LLC, Portland, OR, United States |
| Recall initiated | 2020-08-03 |
| Classified | 2020-10-01 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2022-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,886 |
| Reason classes | potency, sterility, device malfunction |
| UPC / GTIN / UDI-DI | 20884521177403 |
| Lot numbers | 20052017FX |
Product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Reason for recall
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
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-0019-2021. 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.