PlainRecalls
FDA Devices Moderate Class II Terminated

WAVES WCM Kidney Cassette Module

Reported: May 4, 2022 Initiated: March 21, 2022 #Z-1013-2022

Product Description

WAVES WCM Kidney Cassette Module

Reason for Recall

There is a potential for the WCM cassette pump head leaking solution.

Details

Units Affected
75 cases (6ct)
Distribution
WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.
Location
Rochester, MN

Frequently Asked Questions

What product was recalled?
WAVES WCM Kidney Cassette Module. Recalled by Waters Medical Systems LLC. Units affected: 75 cases (6ct).
Why was this product recalled?
There is a potential for the WCM cassette pump head leaking solution.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 4, 2022. Severity: Moderate. Recall number: Z-1013-2022.