Reported May 4, 2022 · Terminated

WAVES WCM Kidney Cassette Module

Waters Medical Systems LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Waters Medical Systems LLC · 2112 15th St NW · Rochester, MN · 55901-0716

Is this the product you have?

  • WAVES WCM Kidney Cassette Module
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberProduct as published
3930005.014Lot 123, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) ; EXP 2022-07-01; UDI (Case): *B154W39300050146/$$32207011236*
3930005.014Lot 124, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) ; EXP 2023-01-05; UDI (Case): *B154W39300050146/$$32301051246*
3930005.014Lot 126, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) ; EXP 2023-05-17; UDI (Case): *B154W39300050146/$$3230517126F*
Amount recalled
75 cases (6ct)

Where it was sold

Why it was recalled

There is a potential for the WCM cassette pump head leaking solution.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Waters Medical Systems LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 16, 2024 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.