FDAFDA · Food and drugs·Recall number Z-0637-2024
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Published January 24, 2024 · Recall initiated: December 12, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Percussionaire Corporation
- Distributor
- US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None
- Lot
- UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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