Recall Z-0619-2007 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C7557
| Date | Mar 14, 2007 (initiated Feb 16, 2007) |
| Status | Terminated |
| Reason | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. |
| Root cause | Other |
| Action | Baxter sent the 2/16/07 Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential disconnections/leaks during use of the Vented Paclitaxel Administration Sets. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any questions were directed to the Center for One Baxter at 1-800-422-9837. |
| Quantity | 15,097 units |
| Distribution | Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981792 | SOLUTION ADMINISTRATION SET Baxter Healthcare Corp, Aug 17, 1998 |