Device product
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Z-0637-2024
Product summary
- Event
- Event 93476
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2145 units
- Official record key
device-enforcement:Z-0637-2024
Official wording
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 information: UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
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
Derived failure modes
-
Manufacturing or process control
assembly error