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Recall

Class II — Fresenius Medical Care Holdings, Inc.

Recalling firmFresenius Medical Care Holdings, Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonFluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
ProductFresenius Liberty® Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Quantity16,600
DistributionUSA Nationwide Distribution
Initiated2013-10-14
Classified2013-11-04
Terminated2021-05-18
Recall numberZ-0148-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Fresenius Medical Care Holdings, Inc. (Z-0148-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66339/

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