Device recall
Z-1068-2019: Laparotomy Sponge with the following product description and model numbers: 1…
FDA device recall · Class II · Medical Action Industries Inc
Key facts
| Recall number (Z-number) | Z-1068-2019 |
|---|---|
| Recall event | 82289 |
| Product | Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model… |
| Product code | GDY |
| Recalling firm | Medical Action Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 6, 2021 |
| FEI number | 1030451 |
At a glance
- None 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