Recall Z-2687-2016 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
| Date | Dec 14, 2012 |
| Status | Terminated |
| Reason | Some of the individual extension set packages were improperly sealed, compromising the sterility of the product. |
| Root cause | Unknown/Undetermined by firm |
| Action | Baxter sent an Urgent Product Recall notification letter dated December 14, 2012, to all affected customers. Baxter instructed customers to locate and remove all affected product from their facility. Customers were instructed to contact Baxter Healthcare Center for Service to arrange for return of product and credit and to complete the attached Customer Reply Form and return it to Baxter or scanned email. Customers with questions should call 1-888-229-0001. For questions regarding this recall call 800-422-9837. |
| Quantity | 15,257 units |
| Distribution | Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042936 | SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE Baxter Healthcare Corp, Nov 26, 2004 |