Device product
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Z-1948-2018
Product summary
- Firm
- Respire Medical
- Event
- Event 80030
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-1948-2018
Official wording
Reason: Potential for device breakage during use
Code information: Serial Numbers: 51366, 51439, 51368, 51577, 51303, 52409, 51985, 51796, 51709, 51744, 51560, 51321, 51545, 51437, 51571, 51576, 51438, 51566, 51509, 51629, 51502, 51409, 51307, 51218, 51154, 51001, 51220, 51153 & 50807
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Potential for device breakage during use