Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0693-2016 · Posted 2016-01-27

Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeFKX
Date Initiated2015-12-15
Date Terminated2019-10-07
Product Quantity14,094 units

Reason for Recall

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).

Firm Action

Fresenius Medical Care issued on December 15, 2015, a n Important Product Notification to all affected customers informing them of the problem and how to recognize the proper latch closing. Questions regarding the contents of the Customer Notification or questions regarding the issue, contact Technical Services at 1-800-227-2572 and reference the Field Action Number FA-2015-10-W. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123630FRESENIUS LIBERTY CYCLERFresenius Medical Care North America, Design Cente · 2013-09-09K043363FRESENIUS LIBERTY CYCLERFresenius Medical Care North America · 2005-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑