WAVES WCM Kidney Cassette Module
FDA Recall Z-1013-2022 · Posted None
Recalling FirmWaters Medical Systems LLC
Recall StatusTerminated
Product CodeKDN
Date Initiated2022-03-21
Date Terminated2024-08-16
Product Quantity75 cases (6ct)
Reason for Recall
There is a potential for the WCM cassette pump head leaking solution.
Firm 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.
Root Cause
Process control
Distribution Pattern
WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.