Riverpoint Medical, LLC recalls Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI:…

Recall date

December 9, 2020

Source

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

Recall number

Z-0949-2021

FDA classification

Class II

Brand / firm

Riverpoint Medical, LLC

Sold / distributed

US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.

Why it was recalled

Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.

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

What was recalled

Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307