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.

Pneupac paraPAC plus 300 ventilator kit Recalled by Smiths Medical ASD Inc. Due to There is a potential for inadvertent tidal volume...

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

Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

Quantity: 2198 units

Why Was This Recalled?

There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.

Where Was This Sold?

Worldwide

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