Recall Z-1275-2024— Smiths Medical ASD Inc.
Class I · Ongoing
Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2024-02-07. It names one FDA 510(k) clearance: K123957. Product: smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS. Reason: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-02-07
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Reason for recall
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.