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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiopulmonary bypass temperature controller

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  Class 2 Device Recall Cardiopulmonary bypass temperature controller see related information
Date Initiated by Firm May 02, 2011
Date Posted July 01, 2011
Recall Status1 Terminated 3 on March 07, 2013
Recall Number Z-2720-2011
Recall Event ID 58971
510(K)Number K811742  
Product Classification Cardiovascular Thermal Regulating System - Product Code DWJ
Product ECMO Heater Model 333, Cardiopulmonary bypass temperature controller.

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 Model: 333  Part Number: 86130 Serial number: 864-E1180 through 924-E2528  
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati OH 45241
For Additional Information Contact
513-772-8810
Manufacturer Reason
for Recall		 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 each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
FDA Determined
Cause 2		 Device Design
Action Cincinnati Sub-Zero Products Inc issued an "Urgeant Medical Device Field Action" letter on May 2, 2011 to all affected customers. The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form. For additional contact the firm at 1-800-989-7373 or (513) 772-8810.
Quantity in Commerce 116 units
Distribution Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, 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.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = CINCINNATI SUB-ZERO
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