Device recall
Z-1699-2016: Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02…
FDA device recall · Class II · Valeant Pharmacueticals International
Key facts
| Recall number (Z-number) | Z-1699-2016 |
|---|---|
| Recall event | 73678 |
| Product | Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container. |
| Recalling firm | Valeant Pharmacueticals International |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 6, 2017 |
| FEI number | 3009443653 |
At a glance
- None 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