Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Prod…

Recall date

June 8, 2018

Source

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

Recall number

Z-2532-2018

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

Japan

Why it was recalled

Products do not meet a tensile strength specification

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

What was recalled

PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)