Smiths Medical Pneupac Plus 300 Ventilator Cycling Malfunction
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall. The malfunction prevents the ventilator from cycling gas delivery as designed, affecting a critical respiratory function. Per the rubric, FDA Class I recalls never fall below Severe (4).
Plain-English summary
Smiths Medical ASD Inc. is recalling the Pneupac paraPAC plus 300 ventilator kit (model REF P300NUS). The recall affects 2,902 units that have been distributed worldwide, including throughout the United States and to over 50 countries internationally.
The ventilators may malfunction when switched to the VENTILATE operating mode. Specifically, the device may intermittently deliver continuous positive airway flow instead of cycling breaths as designed, preventing the ventilator from functioning properly. The device should cycle air delivery to mimic natural human breathing.
Users can identify affected units by checking the serial numbers listed in the FDA recall notice (Z-1275-2024). Healthcare facilities and providers should verify their ventilators against this list and contact Smiths Medical ASD Inc. for further guidance.
The recalled product
- Product
- smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 2,902
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 (20)
- Serial Numbers: 70085
- 70091
- 70096
- 70097
- 70101
- 70103
- 70111
- 70112
- 70114
- 70119
- 70142
- 70171
- 70299
- 1007188
- 1206210
- 1206211
- 1206212
- 1206213
- 1206214
- 1206235
Distribution
Distributed nationwide across the United States.
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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