Waters Medical Systems LLC Recall 89841
Description: WAVES WCM Kidney Cassette Module
Waters Medical Systems LLC Recall 89841 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1013-2022 |
| Event ID | 89841 |
| Event Description | WAVES WCM Kidney Cassette Module |
| Product Type | Devices |
| 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) |
| Recall Reason | There is a potential for the WCM cassette pump head leaking solution. |
| Device Classification | 20220504 |
| Device 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* |
| Center Classification Date | 20220427 |
| Recall Initiation Date | 20220321 |
| Recalling Firm | Waters Medical Systems LLC |
| Initial Notification | Letter |
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