AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Acist Medical Systems
- Recall Initiated
- May 19, 2004
- Posted
- July 20, 2004
- Terminated
- November 3, 2005
- Recall Number
- Z-1002-04
- Quantity
- 3590 kits
- Firm Location
- Eden Prairie, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
Lot / Code Info
Lot # 0584B
Root Cause
Other
Action Taken
Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.
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