Percussionaire Recalls IPV 1 and Phasitron 5 Breathing Circuits for Labeling Update
Percussionaire Corporation is recalling 61,858 units of IPV 1 and Phasitron 5 breathing circuits to update labeling warnings regarding use with volatile anesthetic delivery systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling update to prevent potential adverse effects from device interaction. It fits the 'Moderate' criteria for minor labeling errors or voluntary precautionary recalls, as no injuries or illnesses are reported in the source text.
Plain-English summary
Percussionaire Corporation is recalling 61,858 units of Intrapulmonary Percussive Ventilation (IPV) 1 devices (Product Number: S00065) and Phasitron 5 Breathing Circuits with Unified Connector (Product Number: P5-UC). The recall involves the In-Line Valve Instruction Manual (P20174 Rev D) associated with these products.
The recall is initiated to update labeling to include a warning against using IPV in conjunction with volatile anesthetic delivery systems. The updated warning notes that IPV may alter the controlled delivery of volatile anesthetic agents, which can result in deeper or lighter anesthetic effects. Potential consequences include hypertonia or hypotonia, tachycardia or bradycardia, elevated intracranial pressure, awareness during anesthesia, and oversedation.
The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous countries such as Canada, the United Kingdom, Germany, and Australia. The source text does not specify a date range for distribution or report any specific illnesses or injuries associated with this labeling issue.
The recalled product
- Product
- Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
- Manufacturer
- Percussionaire Corporation
- Affected units
- 61,858
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: S00065/00849436000679
- 00849436000709
- P5-UC/00849436000686 In-Line Valve Instruction Manual: P20174 Rev D
Distribution
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