Fresenius 2008K@home recallZ-3083-2011 · Fresenius Medical Care Holdings, Inc. · initiated May 4, 2011
Terminated All recalls posted in August 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
Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)
FDA root cause category: Device Design
What the company is doing
Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was notified of the retrofit that would be done to their machines. The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit. Please return the receipt for confirmation that you have received this notice. Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.
Recall details
- Recall number
- Z-3083-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 4, 2011
- Posted by the FDA
- Aug 29, 2011
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 705 units
- Product code
- ONW
- FDA submissions
- K070049
- Distribution
- Nationwide Distribution. Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines
Product description
Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Code information (models, lots, serial numbers)
All serial numbers
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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