Recall Z-1461-2018— Cook Inc.

Name: FDA recall Z-1461-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-22

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2018-03-22, terminated 2020-05-13. It names 2 FDA 510(k) clearances: K160753, K992070. Product: Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.. Reason: Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-22
Terminated: 2020-05-13
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K160753 — COOK Vacuum PumpWilliam A. Cook Australia Pty. , Ltd.·cleared 2017-06-13
K992070 — COOK ULTRA QUIET VACUUM PUMP & REGULATORCook Urological, Inc.·cleared 1999-10-27

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

Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.

Reason for recall

Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.

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