Date Initiated by Firm | January 28, 2010 |
Date Posted | April 20, 2010 |
Recall Status1 |
Terminated 3 on July 27, 2012 |
Recall Number | Z-1421-2010 |
Recall Event ID |
54547 |
510(K)Number | K945616 |
Product Classification |
vascular sheath introducer - Product Code DYB
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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 FL 33014-2802
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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 | Package 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 |
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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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510(K) Database | 510(K)s with Product Code = DYB
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