Class 2 Device Recall

• Date Initiated by Firm: July 15, 2003
• Date Posted: August 01, 2003
• Recall Status: Terminated on April 14, 2004
• Recall Number: Z-1075-03
• Recall Event ID: 26836
• PMA Number: P970020S042
• Product: Guidant Multi-Link Zeta Coronary Stent System
• Code Information: 3050632 3060432 3060251 3051952 3052251 3060331 3051231 3051951 3052752 3052031 3051931 3050651 3052752 3060531 3060451 3050751 3052251 3051951 3050931 3050632 3052032 3060251 3051531 3053051 3051634 3051632 3053051 3051531 3052952 3051552 3050931 3052852 3060431 3060432 3050751 3052131 3051532 3052031 3051631 3050251 3043051 3050931 3051531 3051451 3052851 3051551 3051531 3041031
• Recalling Firm/ Manufacturer: Guidant Corporation ACS; 26531 Ynez Road; Temecula CA 92591-4628
• For Additional Information Contact: Michael Schwartz; 909-914-2627
• Manufacturer Reason for Recall: Potential loss of package sterility.
• FDA Determined Cause: Other
• Action: Firm personnel in China have inspected all Chinese consignee end user inventories. Any units found to be defective have been removed and are currently in Guidant control.
• Quantity in Commerce: Not stated
• Distribution: China

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.