Baxter Buretrol Solution Set Recalled Due to Ball-Valve Malfunction
Baxter Healthcare is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing.
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, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP). The product code is 2H7519, and the recall includes all lots. A total of 1,995,040 units are affected. The device is a sterile prescription IV fluid pathway used to administer fluids from a container into a patient's vascular system.
The recall was initiated because Baxter determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected. This malfunction allows air to flow past the valve and into the tubing at the completion of the dose within the burette.
The affected units were distributed worldwide, including US Nationwide and internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom. Healthcare facilities and distributors should stop using the affected devices and follow instructions from Baxter Healthcare Corp. regarding the return or disposal of the product.
The recalled product
- Product
- Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); 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 syste
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 1,995,040
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 2H7519
- 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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