Device recall
Z-1383-05: ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For…
FDA device recall · Class II · Anika Therapeutics, Inc.
Key facts
| Recall number (Z-number) | Z-1383-05 |
|---|---|
| Recall event | 32711 |
| Product | ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC |
| Product code | LZP |
| Recalling firm | Anika Therapeutics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2006 |
| PMA numbers | P000046 |
| FEI number | 3007093114 |
At a glance
- None 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