Device recall
Z-0233-2018: BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage…
FDA device recall · Class II · Dukal Corp.
Key facts
| Recall number (Z-number) | Z-0233-2018 |
|---|---|
| Recall event | 77673 |
| Product | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection. |
| Product code | FPY |
| Recalling firm | Dukal Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2018 |
| FEI number | 1000137528 |
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