Recall Z-0693-2016— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-0693-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-15

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2015-12-15, terminated 2019-10-07. It names 2 FDA 510(k) clearances: K123630, K043363. Product: Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111. Reason: 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)..

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Terminated: 2019-10-07
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K123630 — FRESENIUS LIBERTY CYCLERFresenius Medical Care North America, Design Cente·cleared 2013-09-09
K043363 — FRESENIUS LIBERTY CYCLERFresenius Medical Care North America·cleared 2005-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.