Device recall
Z-1318-2018: Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of…
FDA device recall · Class II · Reliance Medical Products Inc
Key facts
| Recall number (Z-number) | Z-1318-2018 |
|---|---|
| Recall event | 79601 |
| Product | Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor. |
| Product code | HKN |
| Recalling firm | Reliance Medical Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2019 |
| FEI number | 1000136533 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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