Baxter Healthcare Corp.: 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.

Agency Publication Date: October 9, 2012

Affected Products

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 access device.

product code 2C7519, all lots

Lot Numbers:

2C7519

Product: Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL 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 code 2H7519, all lots

Lot Numbers:

2H7519

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.

product code 2C8819, all lots

Lot Numbers:

2C8819

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 vascular system through a vascular access device.

product code 2H8819, all lots

Lot Numbers:

2H8819

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63059

Status: Resolved

Manufacturer: Baxter Healthcare Corp.

Manufactured In: United States

Units Affected: 4 products (278,420 units; 1,995,040 units; 2,265,453 units; 488,504 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

product code 2C7519, all lots

Lot Numbers:

2C7519

product code 2H7519, all lots

Lot Numbers:

2H7519

product code 2C8819, all lots

Lot Numbers:

2C8819

product code 2H8819, all lots

Lot Numbers:

2H8819