Summary
The FDA issued a Class II for WAVES WCM Kidney Cassette Module by Waters Medical Systems LLC. Reason: There is a potential for the WCM cassette pump head leaking solution..
Details
Source
Device Recall
External ID
Z-1013-2022
Action Date
2022-05-04
Status
Terminated
Category
device
Product Description
WAVES WCM Kidney Cassette Module
Lot/Code Info: 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*
Quantity Affected: 75 cases (6ct)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-21
Company
Rochester, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Waters Medical Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Waters Medical Systems LLC have FDA actions?
This is the only FDA action we have on record for Waters Medical Systems LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1013-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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