FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
- Recall number
- Z-0799-2013
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
- Status
- Terminated
- Initiated
- 2012-10-12
- Posted
- 2013-02-11
- Terminated
- 2020-12-30
- Reason
- There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
- Root cause
- Process control
- Action
- Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
- Quantity
- 560 cases, totaling 5590 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot 12BR08009
- 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