Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI 07332414112394, All lots within expiry
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Baxter Healthcare Corporation
Reason for Recall:
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Product Codes/Lot Numbers:

UDI 07332414112394, All lots within expiry

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1122-2021

Related Recalls

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.

Nov 28, 2025 Infusion Pumps Nationwide View Details β†’