Class 2 Device Recall Baxter

• Date Initiated by Firm: December 12, 2002
• Date Posted: January 23, 2003
• Recall Status: Terminated on June 29, 2004
• Recall Number: Z-0457-03
• Recall Event ID: 25210
• 510(K)Number: K003245
• Product Classification: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
• Product: 10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, code 2K6030; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
• Code Information: all lots within expiration date
• 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: Sterility questioned
• FDA Determined Cause: Other
• Action: Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.
• Quantity in Commerce: 388,080 syringes
• Distribution: Nationwide, Canada, Honduras, Indonesia, Israel
• 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 = FOZ