Accutron Recalls Flowmeter Assemblies for Incorrect Nitrous Gas Function
Accutron is recalling specific Flowmeter assemblies used in analgesia gas machines because they function incorrectly when nitrous gas flows without oxygen.
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: The recall involves a medical device with a functional defect that could lead to significant injury or adverse health consequences, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Accutron Inc is recalling specific Flowmeter, CM Assembly units, including Model #27025 and Model #31970, used in Conscious Sedation Unit Analgesia Gas Machines. The recall involves 220 units distributed nationwide in the United States.
The recall is being conducted because the flowmeter functions in an incorrect manner when it flows Nitrous Gas without Oxygen gas being turned on. This malfunction presents a safety risk to patients and operators using the equipment for conscious sedation.
Healthcare providers and consumers should stop using the affected flowmeter assemblies immediately. Users should identify their equipment by checking the model and serial numbers listed in the official recall notice to determine if their units are affected.
The recalled product
- Product
- Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
- Manufacturer
- Accutron Inc
- 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 (2)
- Model#27025: Lot # 73971
- 74929. Model#31970: Lot#74142.
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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