Recall Z-1946-2013— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2013-07-12, terminated 2014-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.. Reason: 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.
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-12
- Terminated
- 2014-09-11
- Firm location
- Portage, MI, United States
Product description
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.