Z-2974-2024 Class I Ongoing
FDA device recall Z-2974-2024 was initiated by Smiths Medical ASD Inc. on May 31, 2024 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 10,240 units.
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