Device recall
Z-0448-2012: Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz…
FDA device recall · Class II · Oculus Innovative Sciences Inc
Key facts
| Recall number (Z-number) | Z-0448-2012 |
|---|---|
| Recall event | 60387 |
| Product | Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics… |
| Product code | FRO |
| Recalling firm | Oculus Innovative Sciences Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2012 |
| 510(k) numbers | K041161, K090206 |
| FEI number | 3004554409 |
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