FDA recall Z-2974-2024

Product

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

Reason for recall

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.

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2024-05-31

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2974-2024