Baxter Recalls Clearlink Buretrol Solution Sets Due to Valve Malfunction
Baxter Healthcare is recalling Clearlink Buretrol Solution Sets because the ball-valve feature may fail, allowing air to enter 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 risk-of-harm product where the valve malfunction allows air into the tubing, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Baxter Healthcare Corp. is recalling the Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber). The affected product code is 2C8819, and the recall includes all lots. A total of 2,265,453 units are involved in this recall.
The recall was initiated because the ball-valve feature of the 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 device is a sterile prescription IV fluid pathway used to administer fluids from a container into a patient's vascular system.
The affected units were distributed worldwide, including nationwide in the United States 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 contact Baxter Healthcare for further instructions.
The recalled product
- Product
- Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink 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 th
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 2,265,453
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 2C8819
- 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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