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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DxTerity Diagnostic Catheter

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 Class 2 Device Recall Medtronic DxTerity Diagnostic Cathetersee related information
Date Initiated by FirmMarch 13, 2018
Date PostedApril 20, 2018
Recall Status1 Terminated 3 on May 07, 2021
Recall NumberZ-1479-2018
Recall Event ID 79591
510(K)NumberK161287 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductMedtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Code Information UDI 20643169689309, Lot Number 60074805
Recalling Firm/
Manufacturer		 Medtronic Vascular
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information ContactJoey Lomicky
763-526-2494
Manufacturer Reason
for Recall		The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
FDA Determined
Cause 2		Packaging
ActionMedtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.
Quantity in Commerce855 units
DistributionUS and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
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 = DQO
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