Fresenius 5008X HDF Hemodialysis Blood Tubing Set Recall Due to Blood Leak Risk
Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to the potential for blood to leak between the venous chamber port and tubing during dialysis treatments.
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: This is a Class II medical device recall with a potential hazard—blood leakage in dialysis tubing—but no reported illnesses, injuries, or hospitalizations in the source text. The device represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the 5008X HDF Hemodialysis Blood Tubing Set due to the potential for blood to leak between the lower port of the venous chamber and the tubing. The recall involves three models: the Standard HDF Bloodline (Model 03-5100-7), the Standard HDF Bloodline with CLIC (Model 03-5100-7C), and the Standard HDF Bloodline with Twister (Model 03-5150-2). These tubing sets are distributed nationwide.
The blood leak could occur during hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration procedures. This potential hazard could affect patients receiving these types of dialysis treatment.
Patients and healthcare facilities should be aware of this potential risk. Healthcare facilities should verify whether they have received any of the affected tubing sets and contact Fresenius Medical Care for guidance on replacement or return of the recalled products.
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.
- Hazard
- blood-leak
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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