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FDAFDA · Food and drugs·Recall number Z-2974-2024

Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

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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