Accutron Recalls Flowmeter Packages for Incorrect Gas Function
Accutron is recalling 220 Flowmeter packages used in analgesia gas machines because they may 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Accutron Inc is recalling 220 units of the CM Flowmeter Pkg H, Model #36700, Serial #13749. These products are used in Conscious Sedation Unit Analgesia Gas Machines. The recall was initiated because the flowmeter functions in an incorrect manner when it flows Nitrous Gas without Oxygen gas being turned on.
The affected products were distributed nationwide in the United States. The recall is classified as Class I by the U.S. Food and Drug Administration. The source text does not specify a lot number, specific distribution dates, or the number of reported injuries or illnesses.
Consumers and healthcare facilities should stop using the affected flowmeter packages immediately. Users should contact Accutron Inc for further instructions on how to return or replace the devices.
The recalled product
- Product
- CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
- Manufacturer
- Accutron Inc
- Hazard
- 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 (1)
- Lot # 75285
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
Same manufacturer · Accutron Inc
See all →- SevereAccutron Recalls Flowmeter Assemblies for Incorrect Nitrous Gas Function
FDA (Devices) · 2012-10-17
- SevereAccutron Newport Portable Analgesia Gas Machine Recalled for Flowmeter Defect
FDA (Devices) · 2012-10-17
- SevereAccutron Recalls Ultra PC Cabinet Mount Packages Due to Flowmeter Defect
FDA (Devices) · 2012-10-17
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