CombiSet True Flow Series, Hemodialysis Blood Tubing with… recallZ-0859-2009 · Fresenius Medical Care North America · initiated Nov 25, 2008
Terminated All recalls posted in January 2009
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 North America 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
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
FDA root cause category: Process control
What the company is doing
Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.
Recall details
- Recall number
- Z-0859-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 25, 2008
- Posted by the FDA
- Jan 23, 2009
- Recalling firm
- Fresenius Medical Care North America
- Quantity
- 57 units
- Product code
- KOC
- FDA submissions
- K022536
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
Product description
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
Code information (models, lots, serial numbers)
Lot number 8LR902 only
Other devices under the same FDA submission
1 device cleared under K022536 — 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 Twister 03-2794-0Fresenius Medical Care Holdings, Inc. · ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS1 death91 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 50491).
- Z-0860-2009 · TerminatedCombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded Comb…
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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