Percussionaire Travel Air and Phasitron 5 Recall for Anesthetic Warning
Percussionaire Corporation is recalling Travel Air and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (anesthetic complications) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Percussionaire Corporation is recalling 228,596 units of Travel Air (Product Number: S00055) and Phasitron 5 (Product Number: P5) devices, along with their associated Instruction Manuals. The recall is driven by a labeling update intended to warn users against using Intrapulmonary Percussive Ventilation (IPV) in conjunction with volatile anesthetic delivery systems.
The updated warning addresses the risk that IPV may alter the controlled delivery of volatile anesthetic agents. This alteration can result in deeper or lighter anesthetic effects, potentially leading to hypertonia or hypotonia, tachycardia or bradycardia, elevated intracranial pressure, awareness during anesthesia, or oversedation.
The affected products were distributed worldwide, including nationwide distribution across the United States and in numerous international countries. Users of these devices should review the updated labeling and discontinue the use of IPV with volatile anesthetic delivery systems as directed by the new warnings.
The recalled product
- Product
- Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
- Manufacturer
- Percussionaire Corporation
- Category
- Medical Device — Ventilation
- Affected units
- 228,596
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number/UDI-DI: S00055/00849436000242
- P5/00849436000501
- Instruction Manual: P20106 Rev B
Distribution
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