Baxter Healthcare Corp.: Medical Device Recall in 2012 - (Recall #: Z-0015-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 vascular system through a vascular access device.

Product Classification:

Class I

Date Initiated: September 7, 2012

Date Posted: October 17, 2012

Recall Number: Z-0015-2013

Event ID: 63059

Reason for Recall:

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.

Status: Terminated

Product Quantity: 488,504 units

Code Information:

product code 2H8819, all lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated