Baxter Gambro Cartridge Blood Set Recalled for Potential Leak Risk
Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential leak between the venous patient connector and the patient's hemodialysis access.
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 structural defect (potential leak) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling Gambro Cartridge Blood Sets, Product Code 101025, intended for single use in hemodialysis treatments using the Phoenix Dialysis Delivery Systems. The recall involves 17,487 units distributed in the United States, Canada, Korea, and Norway.
The recall is being conducted because there is a potential leak between the venous patient connector and the patient's hemodialysis access. This defect could compromise the integrity of the blood circuit during treatment.
Healthcare facilities and patients using these specific blood sets should stop using them and contact Baxter Healthcare Corporation for further instructions or replacement units.
The recalled product
- Product
- Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 17,487
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 (3)
- Product Code: 101025
- Lot 1000276191
- UDI: 37332414007837
Distribution
Distribution scope not specified by the agency.
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