Recall Z-0496-2020
Teleflex Medical · initiated October 4, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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…
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0496-2020
- Initiated
- October 4, 2019
- Product code
- FZP – Clip, Implantable
- Quantity
- 34491 devices
- Distribution
- Worldwide distribution, including US nationwide (including Puerto Rico).
- Recalling firm
- Teleflex Medical, Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0497-2020 Class II | WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965…Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a… | 10/04/2019Open, Classified |