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U.S. Department of Health and Human Services

Class 3 Device Recall Renegade HiFlo

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  Class 3 Device Recall Renegade HiFlo see related information
Date Initiated by Firm August 10, 2005
Date Posted November 01, 2006
Recall Status1 Terminated 3 on May 16, 2012
Recall Number Z-0122-2007
Recall Event ID 36507
510(K)Number K000177  
Product Classification microcatheter - Product Code KRA
Product Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
Code Information Lot Number: 7552069
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760-1536
For Additional Information Contact Robert T. Miragliuolo
508-683-4186
Manufacturer Reason
for Recall		 Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04
FDA Determined
Cause 2		 Other
Action Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.
Quantity in Commerce 5 units
Distribution TX, KY
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.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = BOSTON SCIENTIFIC CORP.
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