Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing… recallZ-0844-2011 · Fresenius Medical Care Holdings, Inc. · initiated Nov 19, 2010
Terminated All recalls posted in January 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
Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
FDA root cause category: Device Design
What the company is doing
Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.
Recall details
- Recall number
- Z-0844-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 19, 2010
- Posted by the FDA
- Jan 10, 2011
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 10, 032 units (418 cases x 24 units)
- Product code
- FJK
- FDA submissions
- K962081
- Distribution
- Distribution Nationwide and Canada
Product description
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
Code information (models, lots, serial numbers)
Lots 09JR01174, 09JR01229, 09NR01139, 10KR01801
Other devices under the same FDA submission
5 devices cleared under K962081 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CombiSet 03-2722-9Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE8 deaths311 reports
- CombiSet 03-2622-3Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE1 death194 reports
- CombiSet 03-2742-9Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE2 deaths85 reports
- CombiSet 03-2621-5Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE4 reports
- CombiSet 03-2630-6Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 57293).
- Z-0843-2011 · TerminatedFresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
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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