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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiopulmonary bypass temperature controllers

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  Class 2 Device Recall Cardiopulmonary bypass temperature controllers see related information
Date Initiated by Firm February 03, 2012
Date Posted May 24, 2012
Recall Status1 Terminated 3 on February 26, 2013
Recall Number Z-1656-2012
Recall Event ID 61754
Product Classification System, thermal regulating - Product Code DWJ
Product ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the fluid temperature. The device is composed of a heater, a circulating pump, fan, safety high limit, and a microprocessor board. Water is heated and pumped from the unit to the heat exchanger. The device can be set so that the operator can monitor the actual water temperature or, with the use of a 400 series probe, the fluid (external) temperature.

This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.
Code Information Serial Numbers: 032-E5201 Through 091-E6690 are subject to recall. The Serial Numbers for the 115V units are as follows:   032-E5201  032-E5202  032-E5203  032-E5204  032-E5205  032-E5226  032-E5227  032-E5228  032-E5229  032-E5230  033-E5286  033-E5287  033-E5288  033-E5289  033-E5290  033-E5306  033-E5307  033-E5308  033-E5309  033-E5310  033-E5311  033-E5312  033-E5313  033-E5314  033-E5315  034-E5327  034-E5328  034-E5329  034-E5330  034-E5331  034-E5332  034-E5333  034-E5334  034-E5335  034-E5336  034-E5352  034-E5353  034-E5354  034-E5355  034-E5356  034-E5367  034-E5388  034-E5369  034-E5370  034-E5371  041-E5422  041-E5423  041-E5424  041-E5425  041-E5426  041-E5442  041-E5443  041-E5444  041-E5445  041-E5446  042-E5502  042-E5503  042-E5504  042-E5505  042-E5506  042-E5507  042-E5508  042-E5509  042-E5510  042-E5511  Q44-E5572  044-E5573  044-E5574  Q44-E5575  Q44-E5591  Q44-E5S92  Q44-E5593  Q44-E5594  051-E5605  052-E5646  052-ES647  052-E5648  052-E5664  052-E5665  052-E5692  052-E5693  052-E5694  052-E5710  052-E5711  052-E5712  052-E5718  053-E5724  053-E5725  053-E5731  053-E5732  053-E5733  053-E5734  053-E5740  053-E5741  053-E5757  053-E5758  053-E5759  053-E5775  053-E5776  053-E5777  053-E5778  053-E5779  054-E5785  054-E5811  054-E5812  054-E5828  054-E5829  054-E5830  054-E5831  054-E5832  054-E5833  054-E5834  054-E5835  054-E5836  054-E5837  054-E5838  054-E5839  054-E5840  061-E5881  061-E5882  061-E5883  061-E5884  061-E5885  061E5901  061-E5902  061-E5903  061-E5904  061-E5905  061-E5927  061-E5928  061-E5904  061-E5930  061-E5931  062-E5952  062-E5953  062-E5954  062-E5955  062-E5956  062-E5957  062-E5958  062-E5959  062-E5960  062-E5961  063-E6003  063-E6004  063-E6005  063-E6006  063-E6007  063-E6013  063-E6014  063-E6015  063-E6016  063-E6017  063-E6018  063-E6019  063-E6020  063-E6021  063-E6022  063-E6028  063-E6029  063-E6030  063-E6031  063-E6032  063-E6033  063-E6034  063-E6035  063-E6036  063-E6037  063-E6038  063-E6039  064-E6040  064-E6041  064-E6042  064-E6043  064-E6044  064-E6089  064-E6090  064-E6091  064-E6092  064-E6093  064-E6119  064-E6120  064-E6121  064-E6122  064-E6123  071-E6129  071-E6130  071-E6131  071-E6132  071-E6133  071-E6134  071-E6150  071-E6151  071-E6152  071-E6153  071-E6154  071-E6160  071-E6161  071-E6162  071-E6163  071-E6164  072-E6180  072-E6181  072-E6182  072-E6183  072-E6184  072-E6196  072-E6197  072-E6198  072-E6199  072-E6200  072-E6206  072-E6207  072-E6208  072-E6209  073-E6277  073-E6278  073-E6279  073-E6280  073-E6281  073-E6292  073-E6293  073-E6294  073-E6295  073-E6296  074-E6297  074-E6298  074"E6299  074-E6300  074-E6301  074-E6318  074-E6319  074-E6320  074-E6327  074-E6328  074-E6329  074-E6330  074-E6331  081-E6363  081-E6364  081-E6365  081-E6366  081-E6367  081-E6378  081-E6379  081-E6360  081-E6381  081-E6382  081-E6393  081-E6394  081-E6395  081-E6396  081-E6397  081-E6429  081-E6430  081-E6431  081-E6432  081-E6433  082-E6454  082-E6455  082-E6456  082-E6457  082-E6458  082-E6494  082-E6495  082-E6496  082-E6497  082-E6498  082-E6519  082-E6520  082-E6521  082-E6522  082-E6523  083-E6614  083-E6615  083-E6616  083-E6617  083-E6618  083-E6619  083-E6620  084-E6621  084-E6622  084-E6623  084-E6624  084-E6625  091-E6651  091-E6652  091-E6653  091-E6654  091-E6655  091-E6686  091-E6687  091-E6668  091-E6689, and  091-E6690.    The Serial Numbers for the 230V units are as follows:   052-E5666 230V, 061-E5911 230V, and 081-E6408 230V.  
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information Contact Beatrice Washington
513-772-8810
Manufacturer Reason
for Recall		 Design error. The probe jack contacts (terminals on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a Service Technician, Operator/User, and/or Patient could be exposed to electric shock during device servicing or use. This situation was ori
FDA Determined
Cause 2		 Device Design
Action Cincinnati Sub-Zero (CSZ) issued an 'URGENT Medical Device Field Action Letter to their customers dated January 31, 2012. The letter was mailed out starting on February 3, 2012. The letter includes: a description of the product and problem, describes the affected Serial Number Range subject to recall/correction and instructs the customers to discontinue using the affected serial-numbered units.The customers are instructed to return the product to their Service Department or Biomedical Engineering Dept. for correction and to complete and mail to CSZ the attached 'Field Action Form.' For additional information, the firm can be reached on a toll-free # 1-800-989-7373.
Quantity in Commerce 298 units (115V=295 and 230V/240V=3)
Distribution AL, AR. AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL,K IN,, KS, LA, MA, MD, MI, MN, MO, NC, NE, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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