Class I — Accutron Inc
| Recalling firm | Accutron Inc |
|---|---|
| Registered facility | ACCUTRON, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| Product | CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine. |
| Quantity | 220 units total |
| Distribution | US Nationwide Distribution |
| Initiated | 2012-04-29 |
| Classified | 2012-10-09 |
| Terminated | 2013-02-01 |
| Recall number | Z-0019-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Accutron Inc (Z-0019-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63174/
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