Device recall
Z-0444-2013: Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The…
FDA device recall · Class II · Metrex Research, LLC.
Key facts
| Recall number (Z-number) | Z-0444-2013 |
|---|---|
| Recall event | 63583 |
| Product | Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. |
| Product code | MMP |
| Recalling firm | Metrex Research, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2012 |
| 510(k) numbers | K962288 |
| FEI number | 1000117344 |
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