Accutron Newport Portable Analgesia Gas Machine Recalled for Flowmeter Defect
Accutron is recalling 220 Newport Portable Analgesia Gas Machines because the flowmeter functions incorrectly when nitrous gas flows without oxygen.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that poses a risk of harm (delivery of gas without oxygen), but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accutron Inc is recalling 220 units of the Newport Portable Package, Model #50000, which serves as a portable analgesia gas machine. The recall covers specific serial numbers and lot numbers distributed nationwide in the United States.
The recall is being issued because the flowmeter functions in an incorrect manner when nitrous gas flows without oxygen gas being turned on. This malfunction could result in the delivery of gas without the required oxygen component.
Healthcare providers and consumers who have these specific units should stop using them immediately and contact Accutron Inc for further instructions on the recall.
The recalled product
- Product
- Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.
- Manufacturer
- Accutron Inc
- Category
- Medical Device — Gas Delivery
- Affected units
- 220
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 (6)
- Lot # 73656
- 74139
- 75209
- 74689
- 75515
- 74858.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Accutron 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.
See all 4 products in this recall →Related recalls
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