PlainRecalls
FDA Devices Critical Class I Ongoing

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

Reported: October 2, 2024 Initiated: May 31, 2024 #Z-3090-2024

Product Description

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

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.

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
11244 units
Distribution
Worldwide distribution.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N. Recalled by Smiths Medical ASD Inc.. Units affected: 11244 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 2, 2024. Severity: Critical. Recall number: Z-3090-2024.