Device recall
Z-0795-2016: PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile…
FDA device recall · Class II · Pharmacaribe llc
Key facts
| Recall number (Z-number) | Z-0795-2016 |
|---|---|
| Recall event | 73053 |
| Product | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated. |
| Product code | CAF |
| Recalling firm | Pharmacaribe llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2017 |
| 510(k) numbers | K130091 |
| FEI number | 3006500694 |
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