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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 08, 2005
Date PostedJanuary 11, 2006
Recall Status1 Terminated 3 on March 16, 2007
Recall NumberZ-0377-06
Recall Event ID 34241
510(K)NumberK780872 
Product Classification Brush, Biopsy, Bronchoscope (Non-Rigid) - Product Code BTG
ProductBoston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501.
Code Information Lots 7579586, 7605110, 7606870, 7606871, 7630518, 7630517, 7628255, 7650452, 7646613, 7664540, 7664221, 7661326, 7668106, 7713491, 7697308, 7701032, 7697695, 7731922, 7730456, 7713492, 7731923, 7750676, 7750675, 7750674, 7766684, 7766527, 7790329, 7769605, 7798015, 7799940, 7807535, 7809850, 7825637, 7825638, 7828001, 7854861, 7853825, 7856736, 7860774, 7874570, 7880712, 7899057, 7898228, 7886786, 7933144, 7929889, 7923394, 7924985 and 7949015.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
508-683-4678
Manufacturer Reason
for Recall		The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.
FDA Determined
Cause 2		Other
ActionConsignees were notified via letter dated December 8, 2005.
Quantity in Commerce12350
DistributionNationwide, Aruba, Australia, Belize, Bolivia, Bulgaria, Chile, China, Dominican Republic, Ecuador, Guatemala, Haiti, Honduras, Hong Kong, India, Indonesia, Israel, Jamaica, Jordan, Korea, Kuwait, Lebanon, Malaysia, Moldavia, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad, Tobago, and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BTG
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