Device recall
Z-1872-2009: ACIST Automated Manifold Kit, REF Model BT2000, SKU # 014613, Sterile R, Made…
FDA device recall · Class II · Acist Medical Systems
Key facts
| Recall number (Z-number) | Z-1872-2009 |
|---|---|
| Recall event | 52199 |
| Product | ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344. The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing… |
| Product code | DXT |
| Recalling firm | Acist Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2012 |
| 510(k) numbers | K040298 |
| 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