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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific Easy Core Biopsy Device

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 Class 3 Device Recall Boston Scientific Easy Core Biopsy Devicesee related information
Date Initiated by FirmOctober 17, 2008
Date PostedJanuary 12, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall NumberZ-0489-2009
Recall Event ID 50087
510(K)NumberK040893 
Product Classification kit, needle, biopsy - Product Code FCG
ProductBoston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-106, REF M0065001060 and M0065001061. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
Code Information Lot 0011524376.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact
508-683-4678
Manufacturer Reason
for Recall		These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionU.S. consignees were notified via letter dated 10/17/08, which informs them of the problem, instructs them to remove from use and quarantine the recalled lots and requests completion and submission of the Reply Verification Tracking form via fax at 508-683-5578. For questions about this recall, contact your local Boston Scientific representative.
Quantity in Commerce14,254 of all devices.
DistributionWorldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.
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 = FCG
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