Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk
Baxter Healthcare is recalling 4,065 Gambro Cartridge Low Weight-Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.
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 with a potential mechanical failure (tubing disconnection) that poses a risk of harm, 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 4,065 units of the Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set. The product is intended for single use in hemodialysis treatments using Dialysis Delivery Systems.
The recall was initiated because of a potential disconnection of the tubing set. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries such as Australia, Canada, and the United Kingdom.
The specific product code is 114435, with UDI 37332414112401. The recall covers lot numbers 1000212228, 1000215484, and 1000224531. Users should stop using the affected blood sets and contact Baxter Healthcare for further instructions.
The recalled product
- Product
- Gambro Cartridge Low Weight-Low Volume 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
- 4,065
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 (5)
- Product Code: 114435
- UDI: 37332414112401
- Lot Numbers: 1000212228
- 1000215484
- 1000224531
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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