Class 1 Device Recall Baxter

• Date Initiated by Firm: October 17, 2002
• Date Posted: February 06, 2003
• Recall Status: Terminated on February 04, 2004
• Recall Number: Z-0521-03
• Recall Event ID: 25088
• 510(K)Number: K791496 K860746
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015
• Code Information: All lots received prior to 10/23/2002
• 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 I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
• FDA Determined Cause: Other
• Action: Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
• Quantity in Commerce: 630,140 units
• Distribution: Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Kong and Nigeria.
• 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