FDA Device Recall Z-0637-2024

Percussionaire Corporation · Sandpoint, ID

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028

Quantity: 2145 units

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

Recall record

Recall number: Z-0637-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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
Recall initiated: 2023-12-12
Classified by FDA Center: 2024-01-17
FDA published: 2024-01-24
Recalling firm: Percussionaire Corporation
Firm location: Sandpoint, ID

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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