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U.S. Department of Health and Human Services

Class 2 Device Recall WECK HemOLok AutoEndo5

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  Class 2 Device Recall WECK HemOLok AutoEndo5 see related information
Date Initiated by Firm October 04, 2019
Create Date November 19, 2019
Recall Status1 Open3, Classified
Recall Number Z-0497-2020
Recall Event ID 84032
510(K)Number K021808  
Product Classification Clip, implantable - Product Code FZP
Product 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
Code Information Codes: 73J1600836 73C1700518 73D1800018 73H1800233 73A1900664 73J1600837 73C1700842 73D1800019 73H1800234 73B1900436 73K1600114 73D1700008 73D1800020 73H1800235 73B1900437 73K1600115 73D1700009 73D1800558 73H1800236 73B1900438 73K1600290 73D1700010 73D1800559 73H1800240  73K1600515 73D1700068 73D1800560 73H1800496  73K1600814 73D1700069 73D1800561 73H1800497  73L1600097 73D1700313 73D1800562 73H1800498  73L1600098 73D1700314 73D1800563 73H1800499  73L1600099 73D1700315 73D1800564 73H1800500  73L1600100 73D1700496 73D1800565 73H1800501  73L1600101 73D1700497 73E1800526 73H1800502  73L1600274 73D1700574 73E1800527 73H1800639  73L1600275 73D1700575 73E1800528 73H1800640  73L1600276 73F1700209 73E1800529 73H1800641  73L1600277 73F1700210 73E1800530 73H1800642  73L1600278 73G1700345 73F1800263 73H1800643  73L1600279 73G1700346 73F1800264 73H1800820  73L1600280 73G1700347 73F1800265 73J1800298  73L1600540 73G1700720 73F1800266 73J1800299  73L1600792 73G1700721 73F1800267 73J1800300  73L1600793 73H1700095 73F1800268 73J1800301  73L1600794 73H1700096 73F1800269 73J1800302  73L1600795 73H1700097 73F1800270 73J1800303  73L1600796 73H1700098 73F1800486 73J1800304  73L1600797 73B1800105 73F1800487 73J1800305  73L1600798 73B1800106 73F1800759 73J1800306  73M1600217 73B1800188 73F1800760 73J1800718  73M1600218 73B1800189 73F1800761 73J1800719  73M1600219 73B1800190 73G1800089 73J1800720  73M1600220 73B1800192 73G1800520 73K1800055  73M1600281 73B1800216 73G1800521 73K1800057  73M1600282 73B1800217 73G1800522 73K1800058  73A1700205 73C1800125 73G1800525 73K1800691  73A1700206 73C1800126 73G1800726 73K1800694  73A1700207 73C1800127 73G1800727 73K1800700  73A1700348 73C1800128 73G1800728 73K1800701  73A1700349 73C1800129 73G1800729 73K1800702  73B1700226 73C1800130 73G1800730 73K1800703  73B1700276 73C1800131 73G1800731 73M1800021  73B1700486 73C1800132 73G1800877 73M1800022  73B1700487 73D1800013 73G1800878 73M1800023  73C1700335 73D1800014 73H1800138 73M1800024  73C1700360 73D1800015 73H1800139 73M1800025  73C1700361 73D1800016 73H1800231 73A1900662  73C1700362 73D1800017 73H1800232 73A1900663  
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Customer Service
866-396-2111
Manufacturer 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).
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified their consignees by letter on 10/04/2019. The letter explained the issue and requested the user discontinue use and contact the company for instructions for their return. Distributors were directed to notify their customers and collect the affected product for return to Teleflex Medical.
Quantity in Commerce 4099 devices
Distribution Worldwide distribution, including US nationwide (including Puerto Rico).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FZP and Original Applicant = WECK
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