Device recall
Z-3202-2018: Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G…
FDA device recall · Class II · ShinChang Medical Co., Ltd.
Key facts
| Recall number (Z-number) | Z-3202-2018 |
|---|---|
| Recall event | 80944 |
| Product | Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.) |
| Product code | FMF |
| Recalling firm | ShinChang Medical Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2023 |
| 510(k) numbers | K993017 |
| FEI number | 3003169040 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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