Pneupac ventilator control knob may shift unintentionally during operation
Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates this defect poses serious risk. The hazard involves unintended movement of a critical control on a life-support device that could impair its intended function.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP due to a potential for inadvertent movement of the tidal volume control knob. This knob can shift from its original setting when the ventilator is set at high (1000-1500 mL) or low (70-150 mL) tidal volumes.
The tidal volume control is critical to the ventilator's operation. Unintended movement of this knob could result in improper ventilator function.
All 10,240 units worldwide with this model number (REF P310NXX) are affected, regardless of serial number.
Patients and healthcare providers using this ventilator should monitor for any unintended changes in the tidal volume setting. Contact Smiths Medical ASD Inc. or your equipment provider for instructions on safe use or replacement.
The recalled product
- Product
- Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 10,240
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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