CLASS II ONGOING Device recall · Reported 25 Jun 2025 · FDA Enforcement Report
5008X HDF Hemodialysis Blood Tubing Set, with the following recalled
Fresenius Medical Care Holdings is recalling 5008X HDF Hemodialysis Blood Tubing Set, with the following, distributed nationwide in the US. The recall was initiated on 29 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1992-2025
- FDA event ID
- 96827
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Apr 2025
- FDA classified
- 18 Jun 2025
- Reported
- 25 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 29 Apr 2025 | Recall initiated by company | |
| 18 Jun 2025 | Classified by FDA | +50 days |
| 25 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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: 03-5150-2.
Where it was distributed
US Nationwide distribution in the state of Massachusetts.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the state of Massachusetts.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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