FDA recall Z-0496-2020

Teleflex Medical · Class II · device

Product

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

Reason for recall

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).

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2019-10-04
Report date: 2019-11-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0496-2020