Recall Z-1013-2022 ยท KDN System, Perfusion, Kidney
Waters Medical Systems LLC
WAVES WCM Kidney Cassette Module
| Date | Mar 21, 2022 |
| Status | Terminated |
| Reason | There is a potential for the WCM cassette pump head leaking solution. |
| Root cause | Process control |
| Action | WMS communicated the recall through a recall letter on 03/15/2022. The letter instructed all customers to return the product to WMS for evaluation. The goal is 100% product location and recovery. In addition, the letter instructed all customers to fill out information on the recall notification and return to WMS. For like product not involved in the recall, a warning letter was issued. For any product not included in the recall but found to be deficient, customers will be instructed to contact WMS for replacement. |
| Quantity | 75 cases (6ct) |
| Distribution | WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111521 | WAVES Waters Medical Systems, LLC, Feb 16, 2012 |