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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 08, 2005
Date Posted January 11, 2006
Recall Status1 Terminated 3 on March 16, 2007
Recall Number Z-0376-06
Recall Event ID 34241
510(K)Number K780872  
Product Classification Brush, Biopsy, Bronchoscope (Non-Rigid) - Product Code BTG
Product Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401.
Code Information Lots 7669915, 7731928, 7809849 and 7580900.
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
Action Consignees were notified via letter dated December 8, 2005.
Quantity in Commerce 600
Distribution Nationwide, 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 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 = BTG and Original Applicant = COOPERVISION, INC.
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