Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1275-2024 — smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

U.S. FDA — Device Enforcement · United States · 2024-02-07 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1275-2024
Date of alert
2024-02-07
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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