Recall Z-0039-05 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
| Date | Oct 22, 2004 (initiated Oct 8, 2004) |
| Status | Terminated |
| Reason | Sterility can be compromised by a component tearing the outer packaging |
| Root cause | Other |
| Action | The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product. |
| Quantity | 1650 kits |
| Distribution | The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc., Jan 10, 2003 |