FDA recall Z-0693-2024

Percussionaire Corporation · Class I · device

Product

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

US: RI, CA, TX

Key facts

Status
Ongoing
Initiation date
2023-03-28
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sandpoint, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2024