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U.S. Department of Health and Human Services

Class 1 Device Recall 5f UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL

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  Class 1 Device Recall 5f UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL see related information
Date Initiated by Firm July 21, 2021
Create Date September 15, 2021
Recall Status1 Open3, Classified
Recall Number Z-2428-2021
Recall Event ID 88372
510(K)Number K992347  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Code Information All codes
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact
786-313-2000
Manufacturer Reason
for Recall		 Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
FDA Determined
Cause 2		 Use error
Action The firm disseminated an Urgent Medical Device Field Correction notice beginning on 07/21/2021. The letter described the problem and provided recommendations for clinical use found in the instructions for use.
Quantity in Commerce 45 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = CORDIS CORP.
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