Z-1013-2022Class II

WAVES WCM Kidney Cassette Module

Name: Z-1013-2022 WAVES WCM Kidney Cassette Module
Creator: Waters Medical Systems LLC
Published: 2022-03-21
License: https://open.fda.gov/license/

Waters Medical Systems LLC / initiated 2022-03-21 / Terminated / root cause: manufacturing process

FDA source

Waters Medical Systems LLC began a recall of WAVES WCM Kidney Cassette Module on 2022-03-21. FDA classified it as Class II and gives the reason as "There is a potential for the WCM cassette pump head leaking solution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1013-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-21
Posted: 2022-04-27
Terminated: 2024-08-16
Recalling firm: Waters Medical Systems LLC
Product: WAVES WCM Kidney Cassette Module
Product code: KDN System, Perfusion, Kidney
Reason for recall: There is a potential for the WCM cassette pump head leaking solution.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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*

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1013-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1013-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-27

Product code KDN

K111521Class IIWavesWaters Medical Systems, LLC / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)