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U.S. Department of Health and Human Services

Class 2 Device Recall Destination Guiding Sheath

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 Class 2 Device Recall Destination Guiding Sheathsee related information
Date Initiated by FirmSeptember 12, 2017
Create DateFebruary 26, 2018
Recall Status1 Terminated 3 on August 31, 2018
Recall NumberZ-0725-2018
Recall Event ID 79167
510(K)NumberK012584 
Product Classification Introducer, catheter - Product Code DYB
ProductDestination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
Code Information Lot: VK09, Expiration Date: 31-Jan-2020
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information ContactTerry Callahan
410-392-7138
Manufacturer Reason
for Recall		The tucking depth feature of this catheter introducer is marginally outside the upper specification.
FDA Determined
Cause 2		Process control
ActionTerumo sent an Urgent Medical Device Recall dated September 12, 2017 to affected customers. The letter identified the affected product problem and actions to be taken. The informed customers that a territory managers will visit each institution to examine the inventory, identify the affected product and lot, and prepare the product for return to Terumo Medical Corporation. There is an inventory confirmation form that is returned by the sales representative to the recalling site.
Quantity in Commerce33
DistributionTo be added.
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 = DYB
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