PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 25, 2018 Initiated: March 22, 2018 #Z-1461-2018

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.

Details

Recalling Firm
Cook Inc.
Units Affected
2,267
Distribution
Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cook Inc.. Units affected: 2,267.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1461-2018.