Fresenius Medical Care—LIBERTY Automated Peritoneal Dialysis System Line Cycler Sets: May Leak and Contaminate Dialysate

February 20, 2013 | Risk Management News

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ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

FDA's Center for Devices and Radiological Health (CDRH) states that the cycler sets below may be punctured and leak, potentially contaminating the dialysate and resulting in peritonitis. FDA's CDRH also states that the manufacturer initiated a recall by Urgent FMCNA LIBERTY Cycler Set Recall letter dated October 31, 2012. The manufacturer has not confirmed the...

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