FDA Device

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.

Hazard

Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

What You Should Do

Remedy

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.

Products

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
Brand
Baxter Healthcare Corp. Route
UPC
product code 2N3345, lot number UR12E03108

Units Affected

15,257 units