# FDA recall Z-1013-2022

> **Waters Medical Systems LLC** · Class II · device recall initiated 2022-03-21.

## Product

WAVES WCM Kidney Cassette Module

## Reason for recall

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.

## Key facts

- **Recall number:** Z-1013-2022
- **Recalling firm:** Waters Medical Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-21
- **Report date:** 2022-05-04
- **Termination date:** 2024-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2022

## Citation

> AI Analytics. FDA recall Z-1013-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1013-2022. Source: US FDA. Licensed CC0.

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