ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS20
FDA device recall Z-0064-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Acist Medical Systems
- Reason for recall
- Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
- Action taken
- The consignees were sent letters dated 10/2/03 which requested that the product be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 7120 kits
- Distribution
- Nationwide in the United States.
- Date initiated
- 2003-10-02
- Date posted
- 2003-10-24
- Date terminated
- 2005-11-23
- 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 |