Device recall
Z-0281-2021: SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven…
FDA device recall · Class II · Sobel Westex
Key facts
| Recall number (Z-number) | Z-0281-2021 |
|---|---|
| Recall event | 86351 |
| Product | SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar. |
| Product code | OEA |
| Recalling firm | Sobel Westex |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2024 |
| FEI number | 3003643727 |
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