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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 FirmJuly 22, 2005
Date PostedSeptember 02, 2005
Recall Status1 Terminated 3 on June 20, 2007
Recall NumberZ-1461-05
Recall Event ID 32694
510(K)NumberK961219 
Product Classification Catheter, Suprapubic (And Accessories) - Product Code KOB
ProductBanana Peel™ Sheaths BP/9/15 Catalog Number: 20-606
Code Information Lot Numbers:   6366302 6388114 6412027 6436181 6444376 6458141 6480766 6484535 6523598 6537720 6560008 6585320 6599016 6620743 6670299 6722845 6765615 6779675 6793496 6835091 7552029 7569737 7592927 7619448 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information ContactCindy Finney
508-683-4678
Manufacturer Reason
for Recall		The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
FDA Determined
Cause 2		Other
ActionBoston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.
DistributionNationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KOB
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