Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle

Recall date

January 10, 2018

Source

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

Recall number

Z-1339-2018

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

Distribution US Nationwide, Canada, India, and Colombia.

Why it was recalled

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

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 Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle