Device recall
Z-0359-2008: ACIST Multi-Use Syringe Kit, Model A2000; SKU #: 014612; labeled as STERILE…
FDA device recall · Class II · Acist Medical Systems
Key facts
| Recall number (Z-number) | Z-0359-2008 |
|---|---|
| Recall event | 45465 |
| Product | ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe… |
| Product code | DXT |
| Recalling firm | Acist Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 6, 2008 |
| 510(k) numbers | K984231 |
| FEI number | 3001726808 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database