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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Flexima Catheter

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  Class 2 Device Recall Boston Scientific Flexima Catheter see related information
Date Initiated by Firm September 21, 2006
Date Posted October 28, 2006
Recall Status1 Terminated 3 on May 03, 2007
Recall Number Z-0081-2007
Recall Event ID 36439
510(K)Number K944290  
Product Classification Catheter - Product Code FFA
Product Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.
Code Information Lot 8955327.
Recalling Firm/
Manufacturer		 Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
For Additional Information Contact Cindy Finney
508-683-4678
Manufacturer Reason
for Recall		 Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.
Quantity in Commerce 80
Distribution Nationwide.
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 = FFA and Original Applicant = BOSTON SCIENTIFIC CORP.
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