Device recall
Z-0838-2022: Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene…
FDA device recall · Class II · Ansell Healthcare Products LLC
Key facts
| Recall number (Z-number) | Z-0838-2022 |
|---|---|
| Recall event | 89691 |
| Product | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 |
| Product code | KGO |
| Recalling firm | Ansell Healthcare Products LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K111139 |
| FEI number | 3011209798 |
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