Teleflex Medical recalls WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are d…

Recall date

October 4, 2019

Source

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

Recall number

Z-0496-2020

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide distribution, including US nationwide (including Puerto Rico).

Why it was recalled

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

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 AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips