Recall Z-0257-05 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
| Date | Nov 24, 2004 (initiated Nov 3, 2004) |
| Status | Terminated |
| Reason | Sterility can be compromised by a tear in the outer packaging. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, China, Canada, France, Taiwan, Thailand, Singapore, Finland, Phillipines, Norway, Netherlands,, Spai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc., Jan 10, 2003 |