Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
FDA device recall Z-0257-05 · posted 2004-11-24 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- Sterility can be compromised by a tear in the outer packaging.
- Action taken
- The recalling firm issued recall letters dated 11/1/04 to their consignees informing them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 875, 798 kits
- Distribution
- The product was shipped to distributors and medical facilities nationwide. The product was also shipped to Saudia Arabia, Kuwaitt, Maylasia, Israel, Chile, Hong Kong, Great Britain, Denmark, Germany,
- Date initiated
- 2004-11-03
- Date posted
- 2004-11-24
- Date terminated
- 2005-04-20
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD STELLANT CT INJECTOR SYSTEM (K023183) | Medrad, Inc. | 2003-01-10 |