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Waters Medical Systems LLC Recall 89841

Description: WAVES WCM Kidney Cassette Module

Waters Medical Systems LLC Recall 89841 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1013-2022
Event ID89841
Event DescriptionWAVES WCM Kidney Cassette Module
Product TypeDevices
DistributionWCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.
Quantity75 cases (6ct)
Recall ReasonThere is a potential for the WCM cassette pump head leaking solution.
Device Classification20220504
Device Code InfoWCM 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*
Center Classification Date20220427
Recall Initiation Date20220321
Recalling FirmWaters Medical Systems LLC
Initial Notification Letter
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