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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Fresenius Medical Care Holdings, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1992-2025
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