Recall Z-0083-2018— Teleflex Medical

Name: FDA recall Z-0083-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-05

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2017-10-05, terminated 2023-01-20. It names one FDA 510(k) clearance: K152081. Product: WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO. Reason: The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2017-10-05
Terminated: 2023-01-20
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K152081 — Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc.·cleared 2015-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.