Z-1950-2018 Class II Terminated
FDA device recall Z-1950-2018 was initiated by Respire Medical on September 1, 2017 and is designated Class II. Reason for recall: Potential for device breakage during use The recall status is terminated (terminated December 9, 2019). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- September 1, 2017
- Termination Date
- December 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Respire Pink H/S Oral Sleep Apnea Device
Reason for Recall
Potential for device breakage during use
Distribution Pattern
US nationwide distribution.
Code Information
Serial Number: 46299