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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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 Class 2 Device Recall Boston Scientificsee related information
Date Initiated by FirmAugust 01, 2003
Date PostedAugust 29, 2003
Recall Status1 Terminated 3 on October 31, 2005
Recall NumberZ-1189-03
Recall Event ID 27034
Product Classification unknown device name - Product Code 74GBK
ProductBoston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter
Code Information Lot 24495
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
For Additional Information ContactPatrick Burt
763-494-1192
Manufacturer Reason
for Recall		Some of the recalled catheters may be in pouches with incomplete seals.
FDA Determined
Cause 2		Other
ActionConsignees were sent a recall letter dated August 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity in Commerce160 catheters (32 boxes of 5 each)
DistributionThe product was shipped 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.
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