Accutron Recalls Ultra PC Cabinet Mount Packages Due to Flowmeter Defect
Accutron is recalling 220 Ultra PC Cabinet Mount Packages because the flowmeter 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 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner."
Plain-English summary
Accutron Inc is recalling 220 units of Ultra PC Cabinet Mount Packages (Models #36600, #36800, #36600-NS, and #36800-NS) distributed nationwide in the United States. The affected products are conscious sedation units and analgesia gas machines.
The recall was initiated because the flowmeter in these devices may function in an incorrect manner when nitrous gas flows without oxygen gas being turned on. This defect poses a risk to patients using the equipment for sedation or analgesia.
Healthcare providers and consumers should stop using the affected units immediately. Accutron Inc is the recalling firm responsible for addressing this safety issue.
The recalled product
- Product
- Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642…
- 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 (20)
- Model #36600
- Lot # 73778
- 73740
- 73851
- 73920
- 74475
- 74035
- 74012
- 74219
- 74118
- 74471
- 75583
- 74372
- 75049
- 74745
- 75283
- 75616
- 75299
- 74926
- 75767
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 →- CriticalAccutron Recalls Flowmeter Packages for Incorrect Gas Function
FDA (Devices) · 2012-10-17
- 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
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