The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0014-2013·Announced 2012-10-17

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.

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 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…
Manufacturer
Baxter Healthcare Corp.
Category
Medical Device — IV Fluid Pathway
Hazard
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.

See all 4 products in this recall →

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