Waters Medical Systems LLC: Medical Device Recall in 2022 - (Recall #: Z-1013-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

WAVES WCM Kidney Cassette Module

Product Classification:

Class II

Date Initiated: March 21, 2022

Date Posted: May 4, 2022

Recall Number: Z-1013-2022

Event ID: 89841

Reason for Recall:

There is a potential for the WCM cassette pump head leaking solution.

Status: Terminated

Product Quantity: 75 cases (6ct)

Code Information:

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*

Distribution Pattern:

WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.

Voluntary or Mandated:

Voluntary: Firm initiated