Device recall
Z-2995-2018: Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC…
FDA device recall · Class II · Ohio Medical Corporation
Key facts
| Recall number (Z-number) | Z-2995-2018 |
|---|---|
| Recall event | 80785 |
| Product | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous… |
| Product code | BTA |
| Recalling firm | Ohio Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2020 |
| 510(k) numbers | K062610 |
| FEI number | 1419185 |
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