Smiths Medical Pneupac paraPAC plus 300 Ventilator Kit Recalled for Knob Movement
Smiths Medical ASD Inc. is recalling Pneupac paraPAC plus 300 ventilator kits because the tidal volume knob may move from its original setting.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Pneupac paraPAC plus 300 ventilator kit, reference number P300NXX. The recall involves 2,198 units distributed worldwide, covering all serial numbers.
The recall is issued due to a potential for inadvertent movement of the tidal volume knob from its original setting. This issue may occur when the knob is set at high (1000-1500 mL) or low (70-150 mL) settings.
The U.S. Food and Drug Administration has classified this as a Class I recall. Users should contact the manufacturer for further instructions regarding the affected devices.
The recalled product
- Product
- Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Ventilator
- Hazard
- Affected units
- 2,198
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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