Class 2 Device Recall Baxter Interlink System

• Date Initiated by Firm: December 18, 2002
• Date Posted: January 16, 2003
• Recall Status: Terminated on September 30, 2003
• Recall Number: Z-0452-03
• Recall Event ID: 25247
• 510(K)Number: K881321
• Product Classification: Set, Transfer (Blood/Plasma) - Product Code KSB
• Product: Y-Type Blood/Solution Set with Pressure Pump, catalog #1C8658; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 109'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015
• Code Information: GR184184, GR186551
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Cetenr for One Baxter; 800-422 Ext. 9837
• Manufacturer Reason for Recall: Leakage may occur at the inlet port
• FDA Determined Cause: Other
• Action: The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.
• Quantity in Commerce: 1,392 sets
• Distribution: Nationwide
• 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 = KSB and Original Applicant = BAXTER HEALTHCARE CORP.