FDA Device Recall Z-2974-2024

Smiths Medical ASD Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

Lot / serial / GTIN: All serial numbers

Quantity: 10,240 units

Reason for recall

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.

Recall record

Recall number: Z-2974-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide
Recall initiated: 2024-05-31
Classified by FDA Center: 2024-09-11
FDA published: 2024-09-18
Recalling firm: Smiths Medical ASD Inc.
Firm location: Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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