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U.S. Department of Health and Human Services

Class 2 Device Recall WAVES WCM Kidney Cassette Module

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 Class 2 Device Recall WAVES WCM Kidney Cassette Modulesee related information
Date Initiated by FirmMarch 21, 2022
Create DateApril 27, 2022
Recall Status1 Terminated 3 on August 16, 2024
Recall NumberZ-1013-2022
Recall Event ID 89841
510(K)NumberK111521 
Product Classification System, perfusion, kidney - Product Code KDN
ProductWAVES WCM Kidney Cassette Module
Code Information 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/$$32207011236* 2) Lot 124, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2023-01-05; UDI (Case): *B154W39300050146/$$32301051246* 3) Lot 126, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2023-05-17; UDI (Case): *B154W39300050146/$$3230517126F*
FEI Number 2123774
Recalling Firm/
Manufacturer		 Waters Medical Systems LLC
2112 15th St NW
Rochester MN 55901-0716
For Additional Information ContactSam Wiegand
507-288-7777
Manufacturer Reason
for Recall		There is a potential for the WCM cassette pump head leaking solution.
FDA Determined
Cause 2		Process control
ActionWMS communicated the recall through a recall letter on 03/15/2022. The letter instructed all customers to return the product to WMS for evaluation. The goal is 100% product location and recovery. In addition, the letter instructed all customers to fill out information on the recall notification and return to WMS. For like product not involved in the recall, a warning letter was issued. For any product not included in the recall but found to be deficient, customers will be instructed to contact WMS for replacement.
Quantity in Commerce75 cases (6ct)
DistributionWCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KDN
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