Device recall
Z-2034-2018: ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR…
FDA device recall · Class II · Joerns Healthcare
Key facts
| Recall number (Z-number) | Z-2034-2018 |
|---|---|
| Recall event | 80113 |
| Product | ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores). |
| Product code | IKY |
| Recalling firm | Joerns Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2023 |
| FEI number | 3009402404 |
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