Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines
Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to reports of kinked access lines observed during treatment.
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 high-risk medical device 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 the Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536. The recall involves 211,155 devices that were distributed worldwide. These products are intended for single use in hemodialysis treatments using the Phoenix Dialysis Delivery Systems.
The recall was initiated after complaints were received regarding kinked access lines observed during treatment using the cartridge sets. The source text does not specify the number of affected patients or report any injuries or illnesses associated with these complaints.
Healthcare providers and patients should stop using the affected devices and contact Baxter Healthcare Corporation for further instructions or replacement units. The recall number is Z-1121-2021.
The recalled product
- Product
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 211,155
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 07332414085216
- 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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