Device recall
Z-2158-2018: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP…
FDA device recall · Class II · Sun Med, LLC
Key facts
| Recall number (Z-number) | Z-2158-2018 |
|---|---|
| Recall event | 80201 |
| Product | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P |
| Product code | BTM |
| Recalling firm | Sun Med, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| 510(k) numbers | K953546 |
| FEI number | 1314417 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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