FDA Enforcement
Class I
Ongoing
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Recall: Z-0693-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0693-2024
- Event ID
- 93648
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Percussionaire Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- March 28, 2023
- Classification Date
- January 17, 2024
- Address
- 130 Mcghee Rd Ste 109, N/A, Sandpoint, ID, 83864-8409, United States
Description
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Reason
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Code Info
UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.
Distribution
US: RI, CA, TX
Quantity
195