Z-0020-2013 Class I Terminated
FDA device recall Z-0020-2013 was initiated by Accutron Inc on April 29, 2012 and is designated Class I. 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. The recall status is terminated (terminated February 1, 2013). Affected quantity: 220 units total.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2012
- Initiation Date
- April 29, 2012
- Termination Date
- February 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 220 units total
Product Description
Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable 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.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot # 73656, 74139, 75209, 74689, 75515, 74858.