Device Recall Model 134, WarmAir Convective Warming Device

Part #86180, Device Listing #D111865, Serial Numbers: 963-1340100 thru 964-1340199; 971-1340200 thru 971-1340294, 973-1340345 thru 973-1340455; 974-1340445 thru 974-1340594; 981-1340605 thru 981-1340674; 983-1340815 thru 983-1340864; 984-1340905 thru 984-1340964; 991-1341025 thru 991-1341064; 992-1341095 thru 992-1341174; 993-1341265 thru 993-1341274; 994-1341365 thru 994-1341374; 001-1341375 thru 001-1341404; 002-1341405 thru 002-1341414; 003-1341415 thru 003-1341424; and 004-1341425-2 thru 004-1341426-2, are subject to recall**.   **Please Note: CSZ serializes the WarmAir 134 devices beginning with the last two digits of the year manufactured, followed by the quarter of manufacture, the numbers "134" and then a sequential number. For example, a unit with serial number 963-1340100 was manufactured in the third quarter of 1996 with a sequential number of 0100.

Cardiovascular Devices

2

No

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.

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.