Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

paraPAC plus 310 ventilator kit with internal PEEP and CPAP Recalled by Smiths Medical ASD Inc. Due to Smiths Medical became aware of an issue related...

Date: May 31, 2024
Company: Smiths Medical ASD Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD Inc. directly.

Affected Products

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

Quantity: 11244 units

Why Was This 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.

Where Was This Sold?

Worldwide distribution.

About Smiths Medical ASD Inc.

Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report