Class 2 Device Recall Baxter Clearlink System Buretrol Solution Set

• Date Initiated by Firm: November 03, 2009
• Date Posted: December 09, 2009
• Recall Status: Terminated on July 08, 2010
• Recall Number: Z-0487-2010
• Recall Event ID: 53751
• 510(K)Number: K984381
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; ; A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device.
• Code Information: Product code 2C8864; Lot number UR09E21238.
• 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 tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.
• FDA Determined Cause: Employee error
• Action: An "Urgent Product Recall" letter dated November 3, 2009 was sent to the direct accounts via first class mail on the same date, to the attention of the Director of Nursing and the Director of Materials Management. The letter informed the accounts that there have been reports of a separation of the tubing from the distal Clearlink Y-site of the set, with one instance resulting in a serious injury. The accounts were instructed to examine their inventory and remove any sets of Product code 2C8864, Lot number UR09E21238 from inventory and return the affected product for credit or replacement product by calling Baxter Healthcare Center for Service at 1-888-229-0001, Prompt 2, during hours of operation 7:00 a.m. to 6:00 p.m. Central Standard Time. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. If the accounts further distributed the Buretrol Sets, they were requested to forward the communication to those accounts. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter.
• Quantity in Commerce: 173 cases
• Distribution: Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada 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 and Original Applicant = BAXTER HEALTHCARE CORP.