Z-1013-2022 Class II Terminated
FDA device recall Z-1013-2022 was initiated by Waters Medical Systems LLC on March 21, 2022 and is designated Class II. Reason for recall: There is a potential for the WCM cassette pump head leaking solution. The recall status is terminated (terminated August 16, 2024). Affected quantity: 75 cases (6ct).
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- March 21, 2022
- Termination Date
- August 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 cases (6ct)
Product Description
WAVES WCM Kidney Cassette Module
Reason for Recall
There is a potential for the WCM cassette pump head leaking solution.
Distribution Pattern
WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.
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*