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

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed… — recall Z-0010-2021

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

As described by U.S. FDA — Device Enforcement: Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - 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,

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0010-2021
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
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution.
Barcode (EAN/GTIN)
20884521153278
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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