Recall Z-0017-2013— Accutron Inc
Class I · Terminated
Class I FDA medical device recall by Accutron Inc, initiated 2012-04-29, terminated 2013-02-01. It names one FDA 510(k) clearance: K052335. 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.. 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..
- Recalling firm
- Accutron Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-04-29
- Terminated
- 2013-02-01
- Firm location
- Phoenix, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.