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Recall Observatory FDA recall evidence

Device 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 through a vascular access device.

Z-0014-2013

September 07, 2012

Class I

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 63059
Status
Terminated
Classification
Class I
Quantity
2,265,453 units
Official record key
device-enforcement:Z-0014-2013

Official wording

Reason: 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.

Code information: product code 2C8819, all lots

Distribution pattern: Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.