CombiSet True Flow" 2008K@home Bloodlines recallZ-3269-2011 · Fresenius Medical Care Holdings, Inc. · initiated Aug 11, 2011
Terminated All recalls posted in September 2011
Is my device affected?
- 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.
- 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.
- 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
Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-3269-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 11, 2011
- Posted by the FDA
- Sep 20, 2011
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 118 cases
- Product code
- ODX
- FDA submissions
- K070049
- Distribution
- Nationwide Distribution.
Product description
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
Code information (models, lots, serial numbers)
Product Code: 03-2962-3 Lot Numbers: 11ER01800 11ER01801 11ER01802 11ER01804 Exp. Date 05-2014
Other devices under the same FDA submission
2 devices cleared under K070049 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 2008® Series Hemodialysis Machines 190828Fresenius Usa, Inc. · Hemodialysis system for home use2 recalls8 reports
- CombiSet 03-2962-3Fresenius Medical Care Holdings, Inc. · Hemodialysis system for home use3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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