Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0693-2016 — Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

U.S. FDA — Device Enforcement · United States · 2015-12-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0693-2016
Date of alert
2015-12-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Renal Therapies Group, LLC
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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