Recall Z-1656-2012 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
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
| Date | May 24, 2012 (initiated Feb 3, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 ad |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.