FDA recall Z-1443-2023
Draeger Medical, Inc. · Class I · device
Product
VentStar Watertrap (P) 180 w/oLL, MP00362
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-1443-2023