Riverpoint Medical product recalled over sterility concerns

Recall date

August 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Riverpoint Medical, LLC recalls Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20…

Recall number

Z-0016-2021

FDA classification

Class II

Brand / firm

Riverpoint Medical, LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - 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.