Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0039-2021 — Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - 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, cardiovasc

U.S. FDA — Device Enforcement · United States · 2020-08-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0039-2021
Date of alert: 2020-08-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Riverpoint Medical, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 20884521152288

Reported risk: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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