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.
FDA Recall Z-1656-2012 · Posted 2012-05-24
Recalling FirmCincinnati Sub-Zero Products Inc
Recall StatusTerminated
Product CodeDWJ
Date Initiated2012-02-03
Date Terminated2013-02-26
Product Quantity298 units (115V=295 and 230V/240V=3)
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.