FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient
- Recall number
- Z-3269-2011
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient
- Status
- Terminated
- Initiated
- 2011-08-11
- Posted
- 2011-09-20
- Terminated
- 2016-08-24
- Reason
- Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions
- Root cause
- Device Design
- Action
- Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers . The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius. For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.
- Quantity
- 118 cases
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Product Code: 03-2962-3 Lot Numbers: 11ER01800 11ER01801 11ER01802 11ER01804 Exp. Date 05-2014
- 510(k) numbers
- ["K070049"]
- PMA numbers
- not on file
- Product code
- ODX
- 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