FDA recall Z-0083-2018

Teleflex Medical · Class II · device

Product

WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

Reason for recall

The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.

Distribution

Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea

Key facts

Status
Terminated
Initiation date
2017-10-05
Report date
2017-11-15
Termination date
2023-01-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Research Triangle Park, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2018