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U.S. Department of Health and Human Services

Class 2 Device Recall IsoGel Air

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 Class 2 Recall
IsoGel Air
see related information
Date Posted August 09, 2013
Recall Status1 Open
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, Michigan 49002-5826
Consumer Instructions Contact the recalling firm for information
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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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