Recall Z-1132-2019— Wilson-Cook Medical Inc.

Name: FDA recall Z-1132-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-04

Class II · Terminated

Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2019-01-04, terminated 2020-07-21. It names one FDA 510(k) clearance: K851958. Product: Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.. Reason: Complaints of the snare loop not completely retracting and/or misshaping of the snare loop..

Recalling firm: Wilson-Cook Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Terminated: 2020-07-21
Firm location: Winston Salem, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K851958 — ROTATABLE POLYPECTOMY SNARE POS-1Wilson-Cook Medical, Inc.·cleared 1985-07-25

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

Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

Reason for recall

Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.

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