Device recall
Z-0744-2016: ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000…
FDA device recall · Class II · Acist Medical Systems
Key facts
| Recall number (Z-number) | Z-0744-2016 |
|---|---|
| Recall event | 72913 |
| Product | ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either… |
| Product code | DXT |
| Recalling firm | Acist Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2016 |
| 510(k) numbers | K052744 |
| 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