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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Scimed Express 2 Monorail

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  Class 2 Device Recall Boston Scientific Scimed Express 2 Monorail see related information
Date Initiated by Firm March 20, 2003
Date Posted April 09, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-0711-03
Recall Event ID 25844
PMA Number P020009 
Product Classification Stent, Coronary - Product Code MAF
Product Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
Code Information Lot number 5140999
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
Manufacturer Reason
for Recall		 The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
FDA Determined
Cause 2		 Other
Action Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them.
Quantity in Commerce 31 stents
Distribution The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
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.
PMA Database PMAs with Product Code = MAF and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
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