Baxter Buretrol Solution Set Recalled for Potential Air Inflow
Baxter is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing at the completion of a dose.
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 medical device defect that poses a risk of harm (air entering the vascular system) 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 Corp. is recalling the Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber). This is a sterile prescription IV fluid pathway device used to administer fluids from a container into a patient's vascular system through a vascular access device.
The recall was initiated because the ball-valve feature of the solution sets may not function as expected. This malfunction could allow air to flow past the valve and into the tubing at the completion of the dose within the burette.
The affected product is identified by product code 2C7519 and includes all lots. A total of 278,420 units were distributed worldwide, including the United States, Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact Baxter for further instructions.
The recalled product
- Product
- Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular acces
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 278,420
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)
- product code 2C7519
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corp. 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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