Baxter Gambro Cartridge Blood Transport System Recalled for Tubing Disconnection Risk
Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems due to a potential disconnection of the tubing set. The recall covers 53,895 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device with a potential mechanical failure (tubing disconnection) that poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling the Gambro Cartridge Blood Transport System for Hemodialysis Blood Set. The recall is being conducted because of a potential disconnection of the tubing set. The product is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
The recall involves 53,895 units. The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous countries across Europe, Asia, the Middle East, and the Americas. Specific lot numbers include 1000205902, 1000214627, 1000222392, and 1000226807.
Healthcare facilities and consumers should stop using the affected blood transport systems and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 53,895
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 (6)
- Product Code: 109536
- UDI: 37332414085217
- Lot Numbers: 1000205902
- 1000214627
- 1000222392
- 1000226807
Distribution
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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