—#94220

Product

LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, 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 09AR08026 1/31/2012 09AR08045 1/31/2012 09AR08046 . 11/30/2011 09AR08092 1/31/2012 09AR08093 1/31/2012 09AR08103 1/31/2012 09AR08104 01/31/2012 09AR08119 11/30/2011 09BR08034 02/29/2012 09BR08035 2/29/2012 09BR08036 02/29/2012 09BR08037 2/29/2012 09BR08038 02/29/2012 09BR08050 2/29/2012 09BR08051 02129/2012 09BR08052 02129/2012 09BR08073 02129/2012 09BR08074 2/29/2012 09BR08801 02/29/2012 09BR08802 02/29/2012 09BR08803 2/29/2012 09CR08018 3/31/2012 09CR08019 3/31/2012 09CR08032 3/31/2012 09CR08033 03/31/2012 09CR08034 3/31/2012 09CR08035 3/31/2012 09CR08095 3/31/2012 09DR08001 4/30/2012 09DR08002 04/30/2012 09DR08023 4/30/2012 09DR08037 4/30/2012 09DR08039 4/30/2012 09DR08040 04130/2012 09ER08093 05131/2012 09ER08094 05131/2012 09ER08095 05131/2012 09ER08096 05131/2012 09ER08097 5/31/2012 09ER08104 05/31/2012 09HR08072 06/30/2012 09HR08073 6/30/2012 09HR08074 06/30/2012 09HR08099 06/30/2012 09HR08100 06/30/2012 09HR08101 6/30/2012 09HR08130 06/30/2012 09HR08131 06/30/2012 09JR08016 07/31/2012 09JR08017 07/31/2012 09JR08018 07/31/2012 09JR08019 7/31/2012 09JR08095 07131/2012 09JR08096 07131/2012 09JR08097 713112012 09JR08106 713112012 09KR08007 813112012

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 #94220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.