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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Profile SingleUse Pediatric Snare

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  Class 2 Device Recall Boston Scientific Profile SingleUse Pediatric Snare see related information
Date Initiated by Firm May 16, 2012
Date Posted June 21, 2012
Recall Status1 Terminated 3 on February 28, 2013
Recall Number Z-1851-2012
Recall Event ID 61935
510(K)Number K941750  
Product Classification Snare, flexible - Product Code FDI
Product Boston Scientific Profile Single-Use Pediatric Snare 13mm
UPN Outer Box: M00562551
Inner Pouch: M00562550

The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Code Information Lot Numbers: 14951482, 14951484, 15068143
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Same
508-683-8000
Manufacturer Reason
for Recall		 Difficulty in extending snare loop from the catheter
FDA Determined
Cause 2		 Process control
Action Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Scan and fax to 508-683-5578. For questions regarding this recall call 508-683-8000.
Quantity in Commerce 1970 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
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 = FDI and Original Applicant = BOSTON SCIENTIFIC CORP.
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