Class 2 Device Recall Baxter NonDEHP MicroVolume Extension Set

• Date Initiated by Firm: December 15, 2005
• Date Posted: March 24, 2006
• Recall Status: Terminated on August 18, 2008
• Recall Number: Z-0631-06
• Recall Event ID: 34290
• 510(K)Number: K811463
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.38mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
• Code Information: product code 2N3345, lots UR254961, UR255216
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
• FDA Determined Cause: Other
• Action: Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
• Quantity in Commerce: 23,950 sets
• Distribution: Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA