Recall Z-0204-2012 ยท DQO Catheter, Intravascular, Diagnostic
Cordis Corporation
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
| Date | Nov 17, 2011 (initiated Nov 21, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 118,690 units |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992347 | CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS Cordis Corp., Oct 8, 1999 |