Device recall
Z-0245-2015: Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to…
FDA device recall · Class I · Customed, Inc
Key facts
| Recall number (Z-number) | Z-0245-2015 |
|---|---|
| Recall event | 69448 |
| Product | Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. |
| Product code | FYA |
| Recalling firm | Customed, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 14, 2017 |
| FEI number | 2648727 |
At a glance
- None Linked 510(k)s
- 100–999 Products in the same recall event
- 100–999 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