Enforcement Report - Week of October 17, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-0017-2013 |
| Classification | Class I |
| Code Info | Model#27025: Lot # 73971, 74929. Model#31970: Lot#74142. |
| Product Distributed Qty | 220 units total |
| 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. |
Event Detail
| Event Id | 63174 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Accutron Inc |
| City | Phoenix |
| State | AZ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-29 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution |
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