WAVES WCM Kidney Cassette Module
Check against the official notice below — it lists the full affected range.
Waters Medical Systems LLC is recalling 75 cases of WAVES WCM Kidney Cassette Modules due to a potential for the WCM cassette pump head to leak solution. The affected product includes three lots: Lot 123 (expiration 2022-07-01), Lot 124 (expiration 2023-01-05), and Lot 126 (expiration 2023-05-17). The cassettes were distributed to one domestic customer with two locations in Tennessee and one international distributor in France.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for the WCM cassette pump head leaking solution.
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. Quantity: 75 cases (6ct) Lot/code info: 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*
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.