Recall Z-1013-2022— Waters Medical Systems LLC

Name: FDA recall Z-1013-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-21

Class II · Terminated

Class II FDA medical device recall by Waters Medical Systems LLC, initiated 2022-03-21, terminated 2024-08-16. It names one FDA 510(k) clearance: K111521. Product: WAVES WCM Kidney Cassette Module. Reason: There is a potential for the WCM cassette pump head leaking solution..

Recalling firm: Waters Medical Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2022-03-21
Terminated: 2024-08-16
Firm location: Rochester, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K111521 — WAVESWaters Medical Systems, LLC·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

WAVES WCM Kidney Cassette Module

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.