Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
FDA device recall Z-0039-05 · posted 2004-10-22 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- Sterility can be compromised by a component tearing the outer packaging
- Action taken
- The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 1650 kits
- Distribution
- The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.
- Date initiated
- 2004-10-08
- Date posted
- 2004-10-22
- Date terminated
- 2005-01-25
- 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 |