Teleflex Medical recalls WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

Recall date

October 5, 2017

Source

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

Recall number

Z-0083-2018

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea

Why it was recalled

The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.

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

What was recalled

WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO