FDA-Device2024-10-02Class I
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Smiths Medical ASD Inc.
Hazard
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.
Sold states
Worldwide distribution.
Affected count
3182 units
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3091-2024Don't want to check this manually?
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