Z-0693-2024 Class I Ongoing
FDA device recall Z-0693-2024 was initiated by Percussionaire Corporation on March 28, 2023 and is designated Class I. Reason for recall: Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy. The recall status is ongoing. Affected quantity: 195.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- March 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 195
Product Description
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Reason for Recall
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Distribution Pattern
US: RI, CA, TX
Code Information
UDI-DI: 00849436000693, Lots/Expiration: WO03739/September 13, 2024, and WO04218/November 14, 2024.