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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Avanti Sheath Introducer

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 Class 2 Recall
Cordis Avanti Sheath Introducer
see related information
Date Posted April 20, 2010
Recall Status1 Terminated on July 27, 2012
Recall Number Z-1421-2010
Recall Event ID 54547
Premarket Notification
510(K) Number
K945616 
Product Classification Introducer, Catheter - Product Code DYB
Product Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.
Code Information Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, and 15076364.
Recalling Firm/
Manufacturer
Cordis Corporation
14201 Nw 60th Ave
Miami Lakes, Florida 33014-2802
For Additional Information Contact Hal Baden
786-313-2000
Manufacturer Reason
for Recall
Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in packing trays.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Cordis initiated the recall January 28, 2010. (The packets were sent overnight on January 28, 2010, with first receipt by customers January 29, 2010.) Immediate corrective action was taken through an inspection and removal of all affected products.
Quantity in Commerce 1850 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = CORDIS CORP.
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