—#94221

Product

LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.

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 Number Expiration Date 09CR08086 03/31/2012 09DR08038 04/30/2012 09JR08092 07/31/2012 09JR08093 07/31/2012 09KR08061 08/31/2012

Why it was recalled

Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution: Throughout USA.

Timeline

Recall initiated: 2010-09-03
Posted by FDA: 2010-10-20
Terminated: 2023-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94221. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.