Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

Recall date

December 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0693-2016

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Nationwide Distribution

Why it was recalled

The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111