Smiths Medical Pneupac paraPAC plus 310 ventilators recalled for malfunction
Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.
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: This is an FDA Class I medical device recall, which mandates a minimum score of 4 per the severity rubric. Although no illnesses or deaths have been reported, the malfunction affects a critical life-sustaining ventilator that may fail to deliver proper respiratory support, presenting substantial risk to patient safety.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP (REF P310NUS). A total of 10,140 units have been distributed worldwide, including throughout the United States and to 48 additional countries.
When the ventilator is switched to VENTILATE operating mode, it may intermittently provide continuous positive gas flow instead of the intended cycling behavior that mimics natural human breathing. This malfunction prevents the device from functioning as designed and poses a risk to patients requiring respiratory support.
Healthcare facilities and providers using affected ventilators should verify the serial numbers of their devices against the list of affected units provided by the manufacturer and the FDA to determine if their equipment is included in this recall.
The recalled product
- Product
- smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 10,140
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: 24224
- 24225
- 130135
- 220977
- 1002250
- 1007181
- 1007187
- 1009159
- 1009160
- 1009161
- 1009162
- 1009163
- 1009186
- 1009187
- 1009188
- 1009189
- 1009190
- 1009230
- 1009231
- 1009232
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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