Skip to content
Recall Observatory FDA recall evidence

Device product

WAVES WCM Kidney Cassette Module

Z-1013-2022

March 21, 2022

Class II

Product summary

Firm
Waters Medical Systems LLC
Event
Event 89841
Status
Terminated
Classification
Class II
Quantity
75 cases (6ct)
Official record key
device-enforcement:Z-1013-2022

Official wording

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

Code information: WCM Kidney Cassette: 1) Lot 123, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2022-07-01; UDI (Case): *B154W39300050146/$$32207011236* 2) Lot 124, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2023-01-05; UDI (Case): *B154W39300050146/$$32301051246* 3) Lot 126, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2023-05-17; UDI (Case): *B154W39300050146/$$3230517126F*

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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