—#122079

Product

Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.

FDA product code: FKX — System, Peritoneal, Automatic Delivery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K043363
Affected lot / code info: All serial numbers

Why it was recalled

Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

Root cause (FDA determination)

Device Design

Action the firm took

Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: USA Nationwide Distribution

Timeline

Recall initiated: 2013-10-14
Posted by FDA: 2013-11-05
Terminated: 2021-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122079. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.