FDA Device recall Z-1013-2022
WAVES WCM Kidney Cassette Module
- FDA Device
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of WAVES WCM Kidney Cassette Module by Waters Medical Systems, citing there is a potential for the WCM cassette pump head leaking solution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1013-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-21 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Waters Medical Systems |
| Distribution | TN |
Product
WAVES WCM Kidney Cassette Module
Reason
There is a potential for the WCM cassette pump head leaking solution.
Identifiers
| code_info | WCM Kidney Cassette: 1) Lot 123, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; W…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* |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1013-2022%22
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