AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
FDA device recall Z-1002-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Acist Medical Systems
- 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.
- Action taken
- Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 3590 kits
- Date initiated
- 2004-05-19
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-03
- Location
- Eden Prairie, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B (K984231) | Invasatec | 2000-05-31 |
| MODIFICATION TO ACIST CL 100H (K991103) | Acist Medical Systems | 2000-05-31 |