Recall Z-2920-2011 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
| Date | Aug 3, 2011 (initiated Jul 21, 2011) |
| Status | Terminated |
| Reason | The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient. |
| Root cause | Employee error |
| Action | Baxter Healthcare Corporation sent a "Urgent Product Recall" letter dated July 21, 2011 to all affected customers. The letter included a description of the problem and requested they contact Baxter at 1-888-229-0001 to return all affected product. They were asked to complete and return the attached customer reply form, and to contact and notify their customers. For questions contact Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. |
| Quantity | 4,752 units |
| Distribution | (USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET Baxter Healthcare Corp, Jun 21, 1996 |