• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

  • Print
  • Share
  • E-mail
-

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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class I 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. 220 units total Z-0018-2013
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. Model#27025: Lot # 73971, 74929. Model#31970: Lot#74142. Class I 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. 220 units total Z-0017-2013
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. Lot # 73656, 74139, 75209, 74689, 75515, 74858. Class I 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. 220 units total Z-0020-2013
CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine. Lot # 75285 Class I 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. 220 units total Z-0019-2013
-
-