FDA Medical Device Recalls (openFDA)
Waters Medical Systems LLC: WAVES WCM Kidney Cassette Module
- Recall number
- Z-1013-2022
- Recalling firm
- Waters Medical Systems LLC
- Product
- WAVES WCM Kidney Cassette Module
- Status
- Terminated
- Initiated
- 2022-03-21
- Posted
- not on file
- Terminated
- 2024-08-16
- 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.
- Lot, serial or model codes
- 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*
- 510(k) numbers
- ["K111521"]
- PMA numbers
- not on file
- Product code
- KDN
- Firm FEI
- 2123774
- Firm city
- Rochester
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28