Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 53
FDA device recall Z-1240-06 · posted 2006-07-13 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- The tip of the catheter may separate from the body during operation.
- Action taken
- The firm sent a letter in June 2006 to its consignees advising them that all impacted lots of Infiniti 6 French catheters (product codes attached) manufactured on Line #1 from July 2005 through February 2006 are being recalled, starting June 26, 2006. The U.S. initial consignee is being contacted directly by Cordis sales reps and other Cordis representatives. The initial consignee is being requested to sign an Acknowledgement Form. The Cordis representative is collecting any units at the consignee, and sending the units back to Cordis for reconciliation and destruction.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 338,270
- Distribution
- Worldwide.
- Date initiated
- 2006-06-26
- Date posted
- 2006-07-13
- Date terminated
- 2008-11-19
- 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 |
|---|---|---|
| 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER (K970854) | Cordis Corp. | 1997-09-30 |
| 1-4F INFINITI ANGIOGRAPHIC CATHETER (K960975) | Cordis Corp. | 1996-04-02 |
| COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD (K911310) | Ge Medical Systems Information Technologies | 1991-06-10 |