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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 22, 2005
Date PostedSeptember 02, 2005
Recall Status1 Terminated 3 on June 20, 2007
Recall NumberZ-1511-05
Recall Event ID 32694
510(K)NumberK962300 
Product Classification Catheter, Suprapubic (And Accessories) - Product Code KOB
ProductTunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK Catalog Number: CVC961IK
Code Information Lot Numbers: 970797 975780 976519 984496 991184 1012876 1014484 1015393 1017361 1018981 1019389 1019740 1025515 1028107 1029092  
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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