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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Scimed

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  Class 2 Device Recall Boston Scientific Scimed see related information
Date Initiated by Firm July 01, 2003
Date Posted August 12, 2003
Recall Status1 Terminated 3 on December 28, 2006
Recall Number Z-1115-03
Recall Event ID 26708
510(K)Number K021735  
Product Classification unknown device name - Product Code GBR
Product Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015

, Product Number H7493791540150
Code Information Lot number 5562834 
Recalling Firm/
Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
For Additional Information Contact Patrick Burt
Manufacturer Reason
for Recall
Some of the product pouches have holes in the seals.
FDA Determined
Cause 2
Action Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity in Commerce 3
Distribution The recalled products were shipped to hospitals located nationwide in the United States.

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 = GBR and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.