| Class 2 Device Recall SUPER TORQUE MB Angiographic Catheter |  |
Date Initiated by Firm | November 21, 2011 |
Date Posted | November 17, 2011 |
Recall Status1 |
Terminated 3 on July 23, 2013 |
Recall Number | Z-0204-2012 |
Recall Event ID |
60392 |
510(K)Number | K992347 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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Product | SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***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 H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6.
UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6.
UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6.
UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10.
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. 532-598A, 532-598B, 532-598C, and 532-598D. |
Recalling Firm/ Manufacturer |
Cordis Corporation 14201 Nw 60th Ave Miami Lakes FL 33014-2802
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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 | 118,690 units |
Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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