Recall Z-1002-04 ยท DXT Injector And Syringe, Angiographic
Acist Medical Systems
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
| Date | Jul 20, 2004 (initiated May 19, 2004) |
| Status | Terminated |
| Reason | Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile. |
| Root cause | Other |
| Action | Each consignee was contacted by telephone and asked to return unused kits with the affected lot number. |
| Quantity | 3590 kits |
| FDA record | Open on fda.gov |