FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: 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.
- Recall number
- Z-0103-2011
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-09-03
- Posted
- 2010-10-20
- Terminated
- 2023-02-16
- Reason
- Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 363,265 units
- Distribution
- Nationwide Distribution: Throughout USA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K043363"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28