Device product
Respire Pink+ Hard Oral Sleep Apnea Device
Z-1949-2018
Product summary
- Firm
- Respire Medical
- Event
- Event 80030
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-1949-2018
Official wording
Reason: Potential for device breakage during use
Code information: Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268 & 52634
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Potential for device breakage during use