Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2974-2024

May 31, 2024

Class I

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 95025
Status
Ongoing
Classification
Class I
Quantity
10,240 units
Official record key
device-enforcement:Z-2974-2024

Official wording

Reason: 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.

Code information: All serial numbers

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.