FDA Enforcement
Class I
Ongoing
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Recall: Z-0637-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0637-2024
- Event ID
- 93476
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Percussionaire Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- December 12, 2023
- Classification Date
- January 17, 2024
- Address
- 130 Mcghee Rd Ste 109, N/A, Sandpoint, ID, 83864-8409, United States
Description
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Reason
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
Code Info
UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
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
Quantity
2145 units