Agency classClass IOur severity:Severe FDA (Devices)·Z-0012-2013·Announced 2012-10-17

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.

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 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…
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — IV Fluid Pathway
Hazard: air-embolism-risk
device-malfunction
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.

See all 4 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · air embolism risk