Device recall
Z-0631-2019: Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown…
FDA device recall · Class II · Cardinal Health 200, LLC
Key facts
| Recall number (Z-number) | Z-0631-2019 |
|---|---|
| Recall event | 81579 |
| Product | Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. |
| Product code | KGO |
| Recalling firm | Cardinal Health 200, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 2025 |
| 510(k) numbers | K113707 |
| FEI number | 3001236905 |
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