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U.S. Department of Health and Human Services

Class 2 Device Recall WECK AutoEndo5

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  Class 2 Device Recall WECK AutoEndo5 see related information
Date Initiated by Firm October 04, 2019
Create Date November 19, 2019
Recall Status1 Open3, Classified
Recall Number Z-0496-2020
Recall Event ID 84032
510(K)Number K152084  
Product Classification Clip, implantable - Product Code FZP
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
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  73F1700597 73M1700020 73C1800265 73E1800326 73F1800733 73F1700598 73M1700074 73C1800266 73E1800327 73F1800734 73F1700599 73M1700112 73C1800267 73E1800328 73G1800171 73G1700468 73M1700113 73C1800268 73E1800329 73G1800172 73G1700469 73M1700114 73C1800515 73E1800330 73G1800264 73G1700472 73M1700115 73C1800516 73E1800331 73G1800265 73G1700473 73M1700116 73C1800517 73E1800332 73G1800266 73G1700554 73M1700286 73C1800578 73E1800333 73G1800267 73G1700555 73M1700287 73C1800627 73E1800334 73G1800289 73G1700556 73M1700288 73C1800628 73E1800764 73G1800290 73G1700557 73M1700289 73C1800629 73E1800765 73G1800291 73G1700558 73M1700290 73C1800630 73E1800766 73G1800292 73H1700821 73M1700291 73C1800631 73E1800767 73G1800293 73H1700835 73A1800244 73C1800632 73E1800768 73G1800294 73H1700836 73A1800589 73C1800633 73E1800769 73G1800295 73K1700553 73A1800596 73D1800209 73E1800770 73G1800296 73K1700567 73A1800597 73D1800210 73E1800771 73G1800868 73K1700568 73A1800598 73D1800211 73E1800772 73G1800872 73K1700570 73A1800605 73D1800212 73F1800091 73G1800873 73K1700571 73A1800742 73D1800213 73F1800092 73G1800874 73L1700001 73A1800823 73D1800372 73F1800093 73G1800875 73L1700002 73A1800824 73D1800373 73F1800094 73G1800876 73L1700004 73A1800825 73D1800374 73F1800095 73H1800071 73L1700007 73A1800827 73D1800375 73F1800096 73H1800140 73L1700023 73A1800828 73D1800376 73F1800097 73H1800141 73L1700107 73B1800286 73D1800377 73F1800098 73H1800142 73L1700108 73B1800287 73D1800668 73F1800099 73H1800143 73L1700189 73B1800288 73E1800023 73F1800407 73H1800144 73L1700190 73B1800289 73E1800024 73F1800408 73H1800145 73L1700277 73B1800291 73E1800025 73F1800409 73H1800228 73L1700278 73B1800292 73E1800026 73F1800410 73H1800229 73L1700280 73B1800468 73E1800027 73F1800411 73H1800638 73L1700281 73B1800469 73E1800028 73F1800412 73H1800829 73L1700282 73B1800525 73E1800033 73F1800586 73H1800830 73L1700351 73B1800526 73E1800034 73F1800587 73J1800030 73L1700462 73B1800527 73E1800165 73F1800588 73J1800031 73L1700463 73B1800528 73E1800166 73F1800589 73J1800032 73L1700464 73B1800529 73E1800167 73F1800590 73J1800033 73L1700465 73B1800676 73E1800198 73F1800591 73J1800034 73L1700466 73B1800677 73E1800199 73F1800675 73J1800035 73L1700467 73B1800678 73E1800200 73F1800727 73J1800036 73L1700587 73B1800679 73E1800201 73F1800728 73J1800385 73L1700588 73B1800680 73E1800202 73F1800729 73J1800386 73L1700589 73B1800681 73E1800203 73F1800730 73J1800387 73L1700590 73C1800263 73E1800204 73F1800731 73J1800388 73L1700591 73C1800264 73E1800325 73F1800732 73J1800480 73J1800481 73L1800353 73A1900048 73B1900227  73J1800482 73L1800354 73A1900049 73B1900228  73J1800483 73L1800355 73A1900233 73B1900229  73J1800484 73L1800356 73A1900234 73B1900230  73J1800485 73L1800357 73A1900235 73B1900231  73J1800486 73L1800358 73A1900236 73B1900429  73J1800487 73L1800359 73A1900237 73B1900430  73J1800488 73L1800541 73A1900238 73B1900431  73J1800716 73L1800542 73A1900239 73B1900432  73J1800717 73L1800543 73A1900240 73B1900433  73K1800059 73L1800544 73A1900241 73B1900434  73K1800060 73L1800545 73A1900431 73B1900617  73K1800062 73L1800546 73A1900432 73B1900618  73K1800063 73L1800547 73A1900433 73B1900619  73K1800064 73L1800549 73A1900434 73B1900620  73K1800065 73L1800550 73A1900435 73B1900621  73K1800132 73L1800728 73A1900436 73B1900622  73K1800133 73L1800729 73A1900437 73B1900623  73K1800134 73L1800731 73A1900438 73B1900624  73K1800336 73L1800732 73A1900439 73B1900625  73K1800337 73L1800733 73A1900656 73C1900028  73K1800338 73L1800734 73A1900657 73C1900029  73K1800339 73L1800735 73A1900658 73C1900030  73K1800340 73L1800736 73A1900659 73C1900031  73K1800341 73M1800226 73A1900660 73C1900032  73K1800342 73M1800227 73A1900661 73C1900033  73K1800894 73M1800228 73A1900869 73C1900034  73K1800895 73M1800229 73A1900870 73C1900035  73K1800896 73M1800266 73A1900871 73C1900036  73K1800897 73M1800267 73A1900872 73C1900239  73K1800898 73M1800268 73A1900873 73C1900240  73K1800899 73M1800269 73A1900874 73C1900241  73K1800900 73M1800270 73A1900875 73C1900242  73K1800901 73M1800271 73B1900050 73C1900243  73K1800902 73M1800272 73B1900051 73C1900244  73L1800094 73M1800273 73B1900052 73C1900245  73L1800095 73M1800474 73B1900053 73C1900437  73L1800096 73A1900032 73B1900054 73C1900439  73L1800097 73A1900033 73B1900055 73C1900440  73L1800098 73A1900041 73B1900056 73C1900442  73L1800099 73A1900042 73B1900057 73C1900444  73L1800100 73A1900043 73B1900058 73C1900445  73L1800101 73A1900044 73B1900223 73C1900446  73L1800102 73A1900045 73B1900224 73C1900447  73L1800351 73A1900046 73B1900225 73C1900448  73L1800352 73A1900047 73B1900226 73C1900609  
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 34491 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 = CORENTEC CO., LTD
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