FDA recall Z-3091-2024

Product

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

Reason for recall

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-05-31

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3091-2024