Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
FDA Recall Z-0148-2014 · Posted 2013-11-05
Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeFKX
Date Initiated2013-10-14
Date Terminated2021-05-18
Product Quantity16,600
Reason for Recall
Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
Firm Action
Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.
Root Cause
Device Design
Distribution Pattern
USA 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.