WAVES WCM Kidney Cassette Module Recalled for Potential Pump Head Leaking
Waters Medical Systems LLC is recalling WAVES WCM Kidney Cassette Modules due to a potential for the pump head to leak solution. The recall affects medical facilities in Tennessee and France.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for malfunction (pump head leak). No illnesses or injuries reported. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Waters Medical Systems LLC is recalling the WAVES WCM Kidney Cassette Module due to a potential defect in which the pump head may leak solution.
The recall involves approximately 75 cases (each containing 6 cassettes) distributed to one domestic customer with two locations in Tennessee and one international distributor located in France. Three affected lot numbers have been identified: Lot 123 (expiration 2022-07-01), Lot 124 (expiration 2023-01-05), and Lot 126 (expiration 2023-05-17).
Affected customers should contact Waters Medical Systems LLC for instructions regarding the recalled units.
The recalled product
- Product
- WAVES WCM Kidney Cassette Module
- Manufacturer
- Waters Medical Systems LLC
- Hazard
- leak
- malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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/$$32207011236* 2) Lot 124
- EXP 2023-01-05
- UDI (Case): *B154W39300050146/$$32301051246* 3) Lot 126
- EXP 2023-05-17
- UDI (Case): *B154W39300050146/$$3230517126F*
Distribution
Distribution scope not specified by the agency.
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