[pending] 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Sta
Pending LLM rewrite. Source: FDA_DEVICE Z-1992-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
The recalled product
- Product
- 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- a. Model Number: 03-5100-7
- UDI-DI: 00840861102365 (Bag)
- 10840861102362 (Case)
- Lot Numbers: 24LR01214
- 24SR01010
- 25ER01800. b. Model Number: 03-5100-7C
- UDI-DI: 0084086110237 (Bag)
- 10840861102379 (Case)
- Lot Number: 24LR01215
- 24SR01011
- 25ER01804. c. Model Number: 03-5150-2
- UDI-DI: 00840861102389 (Bag)
- 10840861102386 (Case)
- Lot Number: 24LR01216
- 24SR01012
- 25ER01805.
Distribution
Distributed nationwide across the United States.
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