Z-0637-2024 Class I Ongoing
FDA device recall Z-0637-2024 was initiated by Percussionaire Corporation on December 12, 2023 and is designated Class I. 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 The recall status is ongoing. Affected quantity: 2145 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- December 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2145 units
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
Distribution Pattern
US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
Code Information
UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028