Covidien LLC recalls Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue a…

Recall date

December 18, 2019

Source

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

Recall number

Z-1295-2020

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

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

What was recalled

Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.