Percussionaire Corporation is recalling Phasitron 5 IPV In-Line Valves because the pressure relief seal may leak when used with a ventilator. This recall affects approximately 59,160 units, including individual valves (REF: P5-TEE) and 20-packs (REF: P5-TEE-20). The manufacturer is advising that these devices should not be used in neonates, infants, patients weighing less than 10kg (approx. 22 lbs), or those requiring target tidal volumes less than 50mL.
A leak in the valve can lead to unrecognized hypoventilation, which significantly increases the risk of respiratory acidosis, low blood oxygen levels (hypoxemia), and respiratory failure, particularly in vulnerable pediatric patients.
Used with In-Line Valve Sentec Instructions for Use P20020 Rev F
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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