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U.S. Department of Health and Human Services

Class 3 Device Recall Mach 1 6F 3.5 JR curve style Guide Catheter

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  Class 3 Device Recall Mach 1 6F 3.5 JR curve style Guide Catheter see related information
Date Initiated by Firm May 24, 2004
Date Posted January 24, 2006
Recall Status1 Terminated 3 on January 23, 2007
Recall Number Z-0433-06
Recall Event ID 32922
510(K)Number K010874  
Product Classification Catheter, Percutaneous - Product Code DQY
Product Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311
Code Information Product UPN H749343566850, Lot # 6287583
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		 Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style.
FDA Determined
Cause 2		 Other
Action A Recall Notice, dated 05/28/05, was sent to Risk Managers. The notice informed them of the issue and instructed them to discontinue use and segregate affected units. A Tracking/verification Form is requested to be returned. Arrangements will be made for returning affected product.
Quantity in Commerce 10 devices
Distribution Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
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 = DQY and Original Applicant = BOSTON SCIENTIFIC CORP.
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