Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in… — Class II medical device recall Z-0347-2014
Terminated recall by Riverpoint Medical, LLC, reported 2013-11-27, distributed in AZ, FL, TX. Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed
| Recall number | Z-0347-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Riverpoint Medical, LLC, Portland, OR, United States |
| Recall initiated | 2012-12-13 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2013-11-21 |
| Distributed | AZ, FL, TX |
| Quantity | 1,932 units |
| Reason classes | labeling |
| Lot numbers | 120716-01 |
Product
Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues
Reason for recall
Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
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-0347-2014. 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.