SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPO
FDA device recall Z-0205-2012 · posted 2011-11-17 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 310 units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico.
- Date initiated
- 2011-11-21
- Date posted
- 2011-11-17
- Date terminated
- 2013-07-23
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS (K992347) | Cordis Corp. | 1999-10-08 |