—#118571

Product

Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.

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 11PR08083

Why it was recalled

Cassette may leak during set up or during peritoneal dialysis treatment

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the 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: 2013-06-03
Posted by FDA: 2013-07-10
Terminated: 2014-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.