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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description 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, 13643, 13644, 13647, 13650, 13669, 13675, 13673, 13678, 13679, 13680, 13683, 13685, 13687, 13691, 13693, 13694, 13695, 13696, 13697, 13701, 13702, 13705, 13706, 13709, 13710, 13711, 13724, 13725, 13728, 13729, 13735, 13739, 13743, 13746, 13750, 13751, 13753, 13754, 13755, 13756, 13760, 13762, 13766, 13774, 13775, 13777, 13781, 13782, 13783, 13785, 13786, 13788, 13792, 13794, 13796, 13799, 13800, 13803, 13804, 13809, 13810, 28298, 28299, 28304, 28305, 28306, 28307, Ultra PC% Cabinet Mount Pkg I, Model #36800, Serial # 13601, 13603, 13607, 13608, 13609, 13613, 13618, 13620, 13623, 13626, 13629, 13630, 13631, 13632, 13641, 13645, 13646, 13648, 13649, 13651, 13652, 13653, 13654, 13655, 13656, 13657, 13658, 13659, 13660, 13661, 13665, 13666, 13667, 13668, 13671, 13672, 13674, 13676, 13677, 13684, 13688, 13689, 13698, 13700, 13707, 13723, 13727, 13730, 13732, 13734, 13741, 13742, 13757, 13758, 13759, 13761, 13762, 13763, 13764, 13765, 13767, 13769, 13789, 13790, 13791, 13795, 13797, 13801, 13802, 13806, 13808, 28300, 28302, 28303, Ultra PC% Cabinet Mount Pkg G, Model#36600-NS, Serial# 13805, 13807, 13811, 13812. Ultra PC% Cabinet Mount Pkg H, Model#36800-NS, Serial# 13744, 13745,13752, 13773, 13774, 13778, 13779, 13780 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Recall Number Z-0018-2013
Classification Class I
Code Info Model #36600, Lot # 73778, 73740, 73851, 73920, 74475, 74035, 74012, 74219, 74118, 74471, 75583, 74372, 75049, 74745, 75049, 75283, 75616, 75299, 74926, 75767, 75344, 75311, 74513. Model #36800, Lot# 73739, 73852, 74011, 73921, 74470, 74032, 74011, 73969, 74139, 74125, 74204, 74220, 74143, 74617, 74573, 74746, 75584, 75449, 74927, 75617, 74568 Model#36600-NS, Lot#75328. Model#36800-NS, Lot#75286.
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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