FDAFDA · Food and drugs·Recall number Z-2973-2024
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
Published September 18, 2024 · Recall initiated: May 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide
- Lot
- All Serial Numbers.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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