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LIBERTY Automated Peritoneal Dialysis System Line Cycler… recallZ-0103-2011 · Fresenius Medical Care Holdings, Inc. · initiated Sep 3, 2010

Terminated All recalls posted in October 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0103-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 3, 2010
Posted by the FDA
Oct 20, 2010
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
363,265 units
Product code
FKX
FDA submissions
K043363
Distribution
Nationwide Distribution: Throughout USA.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

3 devices cleared under K043363 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 56675).

Sources and updates

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