Rochester, MN, United States
Waters Medical Systems LLC recalls
1 recall recorded since 2018, most recently on 21 March 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 March 2022
- Terminated
- 16 August 2024
- Reason
- There is a potential for the WCM cassette pump head leaking solution.
- Distribution
- WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1013-2022
- WAVES WCM Kidney Cassette Module
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.