Baxter Gambro Cartridge Blood Set Prime Line Recalled for Kinked Lines
Baxter Healthcare is recalling Gambro Cartridge Blood Set Prime Line units because kinked access lines were observed during hemodialysis treatments.
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 used for hemodialysis where a functional defect (kinked lines) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling Gambro Cartridge Blood Set Prime Line, product code 101025. The product is intended for single use in hemodialysis treatments using the Phoenix Dialysis Delivery Systems. The recall involves 7,437,480 units with UDI 07332414007836, all lots within expiry, which were distributed worldwide.
The recall was initiated after complaints were received regarding kinked access lines observed during treatment using the cartridge sets. The source text does not report any specific injuries, illnesses, or deaths associated with these complaints.
Healthcare providers and patients should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or replacement units.
The recalled product
- Product
- Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Hemodialysis
- Affected units
- 7,437,480
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 (2)
- UDI 07332414007836
- All lots within expiry
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 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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