Recall Z-2720-2011 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
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.
| Date | Jul 1, 2011 (initiated May 2, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811742 | HEMOTHERM MODEL 400 Cincinnati Sub-Zero, Aug 13, 1981 |