Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices

Fresenius 5008X Hemodialysis Blood Tubing Recalled for Potential Blood Leaks

Agency Publication Date: June 18, 2025
Share:
Sign in to monitor this recall

Summary

Fresenius Medical Care Holdings, Inc. is recalling 2,136 units (89 cases) of 5008X HDF Hemodialysis Blood Tubing Sets because blood may leak where the tubing connects to the lower port of the venous chamber. The recall affects three specific models used for dialysis and ultrafiltration treatments. There have been no reported injuries or incidents associated with this defect.

Risk

A leak in the tubing during medical treatment can result in blood loss for the patient. This risk occurs during various dialysis procedures, including hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

What You Should Do

  1. This recall affects the Fresenius 5008X Standard HDF Bloodline, Standard HDF Bloodline w/CLIC, and Standard HDF Bloodline w/ Twister.
  2. Check your inventory for Model Number 03-5100-7 with lot numbers 24LR01214, 24SR01010, or 25ER01800.
  3. Check for Model Number 03-5100-7C with lot numbers 24LR01215, 24SR01011, or 25ER01804.
  4. Check for Model Number 03-5150-2 with lot numbers 24LR01216, 24SR01012, or 25ER01805.
  5. Stop using the recalled dialysis tubing immediately.
  6. Contact Fresenius Medical Care Holdings, Inc. or your distributor to arrange for the return, replacement, or correction of the affected units.
  7. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: 5008X Standard HDF Bloodline
Variants: 24 units per case
Model / REF:
03-5100-7
Lot Numbers:
24LR01214
24SR01010
25ER01800
UDI:
00840861102365
10840861102362

Model quantity: 76 cases (1,824 eaches).

Product: 5008X Standard HDF Bloodline w/CLIC
Variants: 24 units per case
Model / REF:
03-5100-7C
Lot Numbers:
24LR01215
24SR01011
25ER01804
UDI:
0084086110237
10840861102379

Model quantity: 5 cases (120 eaches).

Product: 5008X Standard HDF Bloodline w/ Twister
Variants: 24 units per case
Model / REF:
03-5150-2
Lot Numbers:
24LR01216
24SR01012
25ER01805
UDI:
00840861102389
10840861102386

Model quantity: 8 cases (192 eaches).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96827
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: Medical Supply Distributors
Manufactured In: United States
Units Affected: Model Number, Cases (Eaches): 03-5100-7, 76 (1,824); 03-5100-7C, 5 (120); 03-5150-2, 8 (192)
Distributed To: Massachusetts
Agency Last Updated: July 9, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.