Class II — Riverpoint Medical, LLC
| Recalling firm | Riverpoint Medical LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. |
| Product | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20884521150925 - 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. |
| Quantity | 1264 |
| Distribution | US Nationwide distribution. |
| Initiated | 2020-08-03 |
| Classified | 2020-10-01 |
| Terminated | 2022-09-08 |
| Recall number | Z-0020-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Riverpoint Medical, LLC (Z-0020-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86254/
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