Device recall
Z-0893-2017: Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd…
FDA device recall · Class II · Ansell Healthcare Products LLC
Key facts
| Recall number (Z-number) | Z-0893-2017 |
|---|---|
| Recall event | 75737 |
| Product | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan… |
| Product code | KGO |
| Recalling firm | Ansell Healthcare Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2017 |
| 510(k) numbers | K984558 |
| FEI number | 3009964047 |
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