Device recall
Z-2741-2018: CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L…
FDA device recall · Class I · Compass Health Brands (Corporate Office)
Key facts
| Recall number (Z-number) | Z-2741-2018 |
|---|---|
| Recall event | 80545 |
| Product | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion… |
| Product code | BZD |
| Recalling firm | Compass Health Brands (Corporate Office) |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 5, 2020 |
| 510(k) numbers | K063268 |
| FEI number | 3012316249 |
At a glance
- 1–9 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