FDA-Device2016-02-03Class II
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
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).
Sold states
Nationwide Distribution
Affected count
14,094 units
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2016Don't want to check this manually?
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