FDA-Device2019-11-27Class II
WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
Teleflex Medical
Hazard
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).
Sold states
Worldwide distribution, including US nationwide (including Puerto Rico).
Affected count
4099 devices
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2020Don't want to check this manually?
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