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Recall Observatory FDA recall evidence

Device product

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

Z-0637-2024

December 12, 2023

Class I

Product summary

Firm
Percussionaire Corporation
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

    reason.manufacturing_process_control · v1.0.0

    assembly error