PlainRecalls
FDA Devices Critical Class I Ongoing

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Reported: January 24, 2024 Initiated: December 12, 2023 #Z-0637-2024

Product Description

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Reason for Recall

Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user

Details

Units Affected
2145 units
Distribution
US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
Location
Sandpoint, ID

Frequently Asked Questions

What product was recalled?
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123. Recalled by Percussionaire Corporation. Units affected: 2145 units.
Why was this product recalled?
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
Which agency issued this recall?
This recall was issued by the FDA Devices on January 24, 2024. Severity: Critical. Recall number: Z-0637-2024.