Percussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
Percussionaire Corporation is recalling 419 Intrapulmonary Percussive Ventilation (IPV) devices to update labeling warnings regarding the use of 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 improper device use, fitting the criteria for moderate severity.
Plain-English summary
Percussionaire Corporation is recalling 419 units of Intrapulmonary Percussive Ventilation (IPV) devices, specifically the IPV HC (Product Number: S00009) and Phasitron P5-HC models. The recall is being conducted to update labeling to include a warning against using IPV in conjunction with volatile anesthetic delivery systems.
The updated warning is necessary because the use of IPV with these systems may alter the controlled delivery of volatile anesthetic agents. This alteration can result in deeper or lighter anesthetic effects, potentially leading to hypertonia, hypotonia, tachycardia, bradycardia, elevated intracranial pressure, awareness during anesthesia, or oversedation.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries. The recall is classified as Class II by the FDA. Healthcare facilities and users should check their inventory for the specific product numbers S00009 and P5-HC and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
- Manufacturer
- Percussionaire Corporation
- Category
- Medical Device — Ventilation
- Affected units
- 419
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 (2)
- Product/Catalog Number/UDI-DI: S00009/00849436000358
- P5-HC/00849436000525
Distribution
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