Z-2974-2024 Class I Ongoing

Recalled by Smiths Medical ASD Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
September 18, 2024
Initiation Date
May 31, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,240 units

Product Description

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 Pattern

Worldwide

Code Information

All serial numbers