Percussionaire In-Line Valve Recalled for Anesthetic Delivery Warning
Percussionaire Corporation is recalling 98,434 In-Line Valves 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 the source text does not explicitly report that injuries or illnesses have already occurred.
Plain-English summary
Percussionaire Corporation is recalling 98,434 units of the In-Line Valve, Product Number P5-TEE. The recall is being conducted to update labeling to include a warning against using intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems.
The updated warning is necessary because IPV may alter the controlled delivery of volatile anesthetic agents. This alteration can result in deeper or lighter anesthetic effects, which may lead to hypertonia or hypotonia, tachycardia or bradycardia, elevated intracranial pressure, awareness during anesthesia, or oversedation.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The source text does not specify specific actions for consumers or healthcare providers beyond the context of the labeling update.
The recalled product
- Product
- In-Line Valve, Product Number: P5-TEE
- Manufacturer
- Percussionaire Corporation
- Affected units
- 98,434
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 (1)
- UDI: 00849436000723
Distribution
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