Device recall
Z-0381-2018: Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product…
FDA device recall · Class II · Owen Mumford USA, Inc.
Key facts
| Recall number (Z-number) | Z-0381-2018 |
|---|---|
| Recall event | 78483 |
| Product | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. |
| Product code | FMI |
| Recalling firm | Owen Mumford USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2021 |
| 510(k) numbers | K152339 |
| FEI number | 1000219614 |
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