Fresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks
Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to potential blood leaks between the venous chamber and tubing. The recall affects hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration procedures nationwide.
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 an FDA Class II medical device recall involving a structural/functional defect (potential blood leak) in critical renal replacement therapy equipment. Although no reported illnesses or injuries are stated in the source, the hazard presents a risk of harm in high-risk clinical settings where blood loss or treatment interruption could cause serious consequences.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 5008X HDF Hemodialysis Blood Tubing Sets in three models (03-5100-7, 03-5100-7C, and 03-5150-2) distributed nationwide. The recalled units total 76, 5, and 8 cases respectively. This is a Class II recall.
The tubing sets may develop blood leaks at the connection between the lower port of the venous chamber and the tubing. This potential defect affects blood tubing used in multiple forms of renal replacement therapy: hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration procedures.
Patients and healthcare providers using these tubing sets should discontinue use and contact Fresenius Medical Care Holdings, Inc. for instructions on replacement or return of the affected product. Specific lot numbers and UDI codes are available for identification of affected units.
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
- device-defect
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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