Device recall
Z-2640-2024: Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a…
FDA device recall · Class II · Microtek Medical Inc.
Key facts
| Recall number (Z-number) | Z-2640-2024 |
|---|---|
| Recall event | 94780 |
| Product | Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). |
| Product code | KPE |
| Recalling firm | Microtek Medical Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K811233 |
| FEI number | 3014342658 |
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