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U.S. Department of Health and Human Services

Class 2 Device Recall SUPER TORQUE MB Angiographic Catheter

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  Class 2 Device Recall SUPER TORQUE MB Angiographic Catheter see related information
Date Initiated by Firm November 21, 2011
Date Posted November 17, 2011
Recall Status1 Terminated 3 on July 23, 2013
Recall Number Z-0205-2012
Recall Event ID 60392
510(K)Number K992347  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***Sterile EO***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***"

UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2.

UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4.

Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
Code Information Not Lot Specific. Catalog No. SRD5724MB and SRD5727MB.
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact Hal Baden
786-313-2000
Manufacturer Reason
for Recall		 Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A, 532598B, 532598C, 532598D, SRD5724MB and SRD5727MB are affected by the Cordis Correction.
FDA Determined
Cause 2		 Error in labeling
Action Cordis Corporation sent a Correction letter dated November 21, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are instructed to read the "Description" and "Recommendations" sections, sign and return an enclosed Acknowledgement Form, and to maintain awareness of the communication until the information has been incorporated into the Cordis Super Torque MB Catheter labeling. Contact Cordis at 800-781-0282 for questions regarding this notice.
Quantity in Commerce 310 units
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = CORDIS CORP.
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