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Stryker Medical Division of Stryker Corporation recalls IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Recalled August 21, 2013 · FDA recall Z-1946-2013 · Stryker Medical Division of Stryker
Hazard
Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi · FDA Class II
Units
586 units
Sold at
Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.
Description
Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi
Product
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Manufacturer(s)
Stryker Medical Division of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →