Recall Z-0013-2013 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
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.
| Date | Oct 9, 2012 (initiated Sep 7, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 1,995,040 units |
| Distribution | Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984381 | BURETROL SOLUTION SETS Baxter Healthcare Corp, Feb 19, 1999 |