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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 May 07, 2003
Date Posted May 22, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall Number Z-0862-03
Recall Event ID 26264
PMA Number P970020S030 
Product Classification Stent, Coronary - Product Code MAF
Product MULTI-LINK Pixel Coronary Stent System
Size: 2.0 x 13 mm OTW
Part Number: 1007830-13
Code Information Lot 3021951
Recalling Firm/
Manufacturer
Guidant Corporation ACS
26531 Ynez Road
Temecula CA 92591-4628
For Additional Information Contact James C. McMahon
909-914-2298
Manufacturer Reason
for Recall
Sterility compromised.
FDA Determined
Cause 2
Other
Action The firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.
Quantity in Commerce 40
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.
PMA Database PMAs with Product Code = MAF and Original Applicant = ABBOTT VASCULAR INC.
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