Device recall
Z-0071-2018: AERO IOL Injection System containing 10 Z28 Cartridges per box, Part…
FDA device recall · Class II · Aaren Scientific Inc.
Key facts
| Recall number (Z-number) | Z-0071-2018 |
|---|---|
| Recall event | 78037 |
| Product | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's. |
| Product code | MSS |
| Recalling firm | Aaren Scientific Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2018 |
| 510(k) numbers | K123888 |
| FEI number | 3010126268 |
At a glance
- 1–9 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