FDA-Device2022-05-04Class II
WAVES WCM Kidney Cassette Module
Waters Medical Systems LLC
Hazard
There is a potential for the WCM cassette pump head leaking solution.
Sold states
WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.
Affected count
75 cases (6ct)
Manufactured in
2112 15th St NW, Rochester, MN, United States
Products
WAVES WCM Kidney Cassette Module
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2022Don't want to check this manually?
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