FDA Recall
Terminated
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
Recall: Z-1002-04
·
Initiated May 19, 2004
Recall
- Recall Number
- Z-1002-04
- Event Number
- 29159
- Firm
- Acist Medical Systems
- FEI Number
- 3001726808
- Product Code
- DXT
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 19, 2004
- Posted
- July 20, 2004
- Terminated
- November 3, 2005
- Address
- 7450 Flying Cloud Dr, Ste 150, Eden Prairie, MN, 55344-3720
Description
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
Reason
Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
Action
Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.
Quantity
3590 kits