Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
FDA Recall Z-1674-2013 · Posted 2013-07-10
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeFKX
Date Initiated2013-06-03
Date Terminated2014-06-18
Product Quantity5480 units
Reason for Recall
Cassette may leak during set up or during peritoneal dialysis treatment
Firm Action
Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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