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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 15, 2003
Date Posted August 01, 2003
Recall Status1 Terminated 3 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 2		 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.
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