Baxter Recalls Clearlink System Buretrol Solution Sets Due to Valve Malfunction
Baxter Healthcare is recalling 488,504 units of Clearlink System Buretrol Solution Sets because the ball-valve feature may allow air to enter the tubing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette."
Plain-English summary
Baxter Healthcare Corp. is recalling 488,504 units of the Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP). The product code is 2H8819, and the recall includes all lots. These sterile prescription IV fluid pathway devices are 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 nationwide in the United States and internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink 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…
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 488,504
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 2H8819
- 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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