FDAFDA · Food and drugs·Recall number Z-1459-2023
Set2Go Ventilation 12 (A), MP07968
Published May 24, 2023 · Recall initiated: April 17, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draeger Medical, Inc.
- Distributor
- Domestic: US Nationwide Distribution.
- Lot
- UDI-DI: 04048675544739; All lots.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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