—#112404

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K984381
Affected lot / code info: product code 2H8819, all lots

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Baxter Healthcare Corp. sent an Urgent Product Recall letter dated September 7, 2012, via first class mail to all affected customers, informing them of the problem with the ball-valve, and instructing them to discontinue use of the affected product and to contact Baxter for instructions to return the affected product.. The customers were also requested to complete the attached customer reply form, confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

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

Timeline

Recall initiated: 2012-09-07
Posted by FDA: 2012-10-09
Terminated: 2017-12-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112404. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.