Medical device recalls Moderate risk

Waters Medical Systems LLC recalls WAVES WCM Kidney Cassette Module

Recall date
March 21, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1013-2022
FDA classification
Class II
Brand / firm
Waters Medical Systems LLC
Sold / distributed
WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

WAVES WCM Kidney Cassette Module

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