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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific SpyGlass Light Cable

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  Class 2 Device Recall Boston Scientific SpyGlass Light Cable see related information
Date Initiated by Firm February 07, 2007
Date Posted March 31, 2007
Recall Status1 Terminated 3 on November 15, 2007
Recall Number Z-0698-2007
Recall Event ID 37403
510(K)Number K864387  
Product Classification Light cable - Product Code EQH
Product Boston Scientific SpyGlass Light Cable
Reference Number: 4621 UPN M00546210
Code Information Lot Number: 355R
Recalling Firm/
Manufacturer
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Debra Prout
508-683-4433
Manufacturer Reason
for Recall
Light Degradation in transmission-A film may deposit on the front face and limit transmission of light
FDA Determined
Cause 2
Other
Action Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Quantity in Commerce 13 units
Distribution Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
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 = EQH and Original Applicant = LUXTEC CORP.
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