—#115494

Product

Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. 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: Lot 12BR08009

Why it was recalled

There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

Root cause (FDA determination)

Process control

Action the firm took

Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2012-10-12
Posted by FDA: 2013-02-11
Terminated: 2020-12-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115494. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.