Ethicon, Inc. recalls ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND…

Recall date

April 19, 2019

Source

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

Recall number

Z-1841-2019

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada

Why it was recalled

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

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

What was recalled

ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures