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U.S. Department of Health and Human Services

Class 3 Device Recall Renegade

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  Class 3 Device Recall Renegade see related information
Date Initiated by Firm October 13, 2006
Date Posted November 14, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall Number Z-0177-2007
Recall Event ID 36629
510(K)Number K973645  
Product Classification Catheter - Product Code KRA
Product Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
Code Information Lot #: 7513978
Recalling Firm/
Manufacturer		 Boston Scientific Target
4701 Lakeview Blvd
Fremont CA 94537
For Additional Information Contact Irene Jaworski
510-624-1580
Manufacturer Reason
for Recall		 Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)
FDA Determined
Cause 2		 Other
Action On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return.
Quantity in Commerce 54 units
Distribution Class III Recall-Worldwide-USA and Australia
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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