Baxter Recalls Gambro Hemodialysis Blood Sets Due to Kinked Lines
Baxter Healthcare is recalling Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis because of complaints regarding kinked access lines observed during treatment.
What this means for you
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 to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling 25,785 units of the Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435. The devices 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 affected devices have UDI 07332414112400 and are distributed worldwide. All lots within expiry are included in this recall.
Healthcare facilities and users should stop using the affected blood sets and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 25,785
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 07332414112400
- 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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