FDA recall Z-1013-2022

Waters Medical Systems LLC · Class II · device

Product

WAVES WCM Kidney Cassette Module

Reason for recall

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

Distribution

WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.

Key facts

Status: Terminated
Initiation date: 2022-03-21
Report date: 2022-05-04
Termination date: 2024-08-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rochester, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2022