Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; a...
FDA Recall #Z-2687-2016 — Class II — December 14, 2012
Product Description
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.
Reason for Recall
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
Recalling Firm
Baxter Healthcare Corp. — Round Lake, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
product code 2N3345, lot number UR12E03108
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated