FDA recall Z-1457-2023
Draeger Medical, Inc. · Class I · device
Product
Ventstar Coax 230, MP03376
Reason for recall
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Distribution
Domestic: US Nationwide Distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2023-04-17
- Report date
- 2023-05-24
- Termination date
- 2024-09-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Telford, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2023