WAVES WCM Kidney Cassette Module (Waters Medical Systems) – Potential Leakage (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WAVES WCM Kidney Cassette Module
Brand
Waters Medical Systems LLC
Lot Codes / Batch Numbers
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/$$3230517126F*
Products Sold
WCM Kidney Cassette: 1) Lot 123, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2022-07-01; UDI (Case): *B154W39300050146/$$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*
Waters Medical Systems LLC is recalling WAVES WCM Kidney Cassette Module due to There is a potential for the WCM cassette pump head leaking solution.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for the WCM cassette pump head leaking solution.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, TN
Page updated: Jan 10, 2026