Class 2 Device Recall IsoGel Air

• Date Initiated by Firm: July 12, 2013
• Date Posted: August 09, 2013
• Recall Status: Terminated on September 11, 2014
• Recall Number: Z-1946-2013
• Recall Event ID: 65337
• Product Classification: Bed, flotation therapy, powered - Product Code IOQ
• Product: IsoGel AIR 84, Support Surface.; ; Intended to assist in improving human patient outcomes.
• Code Information: Model Numbers: 2860-000-001 and 2860-000-002 and serial numbers: 121228600100355, 121228600100356, 121228600100357, 121228600200315, 121228600200316 121228600200322, 121228600200323, 121228600200324, 121228600200325, 121228600200326 121228600200332, 121228600200333, 121228600200334, 121228600200335, 121228600200336 121228600200342, 121228600200343, 121228600200344, 121228600200345, 121228600200346 121228600200352, 121228600200353, 121228600200367, 121228600200368, 121228600200369 121228600200375, 121228600200376, 121228600200377, 121228600200378, 121228600200379 121228600200386, 121228600200393, 121228600200394, 121228600200395, 121228600200396 121228600200402, 121228600200403, 121228600200404, 121228600200405, 011328600100406 011328600100412, 011328600100413, 011328600100414, 011328600100415, 011328600100416 011328600100422, 011328600100423, 011328600100424, 011328600100425, 011328600100426 011328600100432, 011328600100433, 011328600100434, 011328600100435, 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• Recalling Firm/ Manufacturer: Stryker Medical Division of Stryker Corporation; 3800 E Centre Ave; Portage MI 49002-5826
• For Additional Information Contact: Dennis Waters; 269-389-8129
• Manufacturer 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
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 7/12/13, an URGENT MEDICAL DEVICE RECALL NOTIFICATION was mailed to consignees. The notification addressed the affected product and issue, potential hazard, actions needed including faxing (269-488-8691) or emailing (ProductFieldAction@stryker.com) the attached reply form to confirm receipt of notification, and risk mitigation. Please contact the firm at 269-389-8129 if you have questions or concerns regarding this recall. Business hours are M-F 8am-5pm(ET).
• Quantity in Commerce: 586 units
• Distribution: Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.