Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. The device draws in room air through a filter by means of an electric blower. It heats the air to the desired temperature by controlling the air temperature entering a flexible connecting hose, and conveys it to the disposable blanket (i.e. FilteredFlow Blankets, Warming Tube) in contact with the patient, in order to warm the patient. This device provides a continuous flow of heated air as a means of warming patients suffering the common, but significant problems of hypothermia. The system can be used in Post Anesthesia Care Units (PACUs), Intensive Care Units (ICUs), Surgical Intensive Care Units (SICUs), Emergency Rooms (ERs), Operating Rooms (ORs), or any other departments or hospital facilities requiring patient temperature management.
FDA Recall Z-2800-2011 · Posted 2011-07-14
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Recalling FirmCincinnati Sub-Zero Products Inc
Recall StatusTerminated
Product CodeDWJ
Date Initiated2011-05-19
Date Terminated2013-02-26
Product Quantity463 units were distributed
Reason for Recall
A component defect. The recalling firm determined that one of the connectors attached to the firm's WarmAir 134 device's Printed Circuit Board (PCB) can overheat. Should this event occur, the excess heat build up within the device may result in damage to the device's external case and/or melting of some of the internal components of the unit.
Firm Action
CSZ Cincinnati Sub-Zero sent an "URGENT MEDICAL DEVICE RECALL FIELD ACTION" notice to all affected customers. The letter identifies the product, problem, and actions to be taken.
CSZ instructs customers to complete and return an enclosed recall response form and to state whether or not their facility is in possession of the device. The completed form should be returned via fax at 513-772-9119 or via e-mail to [email protected]. Additionally, customers are instructed to discontinue use of the device and return to their Biomedical Engineering and/or Service Department for device exchange and return.
Questions regarding this notice are directed to the WarmAir 134 field action (recall) administrator at 1-800-989-7373.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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