Device recall
Z-0681-2019: Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with…
FDA device recall · Class II · Medical Action Industries Inc
Key facts
| Recall number (Z-number) | Z-0681-2019 |
|---|---|
| Recall event | 81640 |
| Product | Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal… |
| Product code | GDY |
| Recalling firm | Medical Action Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2019 |
| 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