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U.S. Department of Health and Human Services

Class 2 Device Recall IsoGel Air

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 Class 2 Device Recall IsoGel Air see related information
Date Posted August 09, 2013
Recall Status1 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, 011328600100436
011328600100442, 011328600100443, 011328600100444, 011328600100445, 011328600100446
011328600100452, 011328600100453, 011328600100454, 011328600100455, 011328600100456
011328600100462, 011328600100463, 011328600100464, 011328600100465, 011328600100466
011328600100474, 011328600100475, 011328600100476, 011328600100477, 011328600100478
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011328600100783, 011328600100784, 011328600100785, 011328600100786, 011328600100787
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011328600200511, 011328600200512, 011328600200513, 011328600200514, 011328600200515
011328600200526, 011328600200527, 011328600200528, 011328600200529, 011328600200530
011328600200536, 011328600200537, 011328600200538, 011328600200539, 011328600200540
011328600200546, 011328600200547, 011328600200548, 011328600200549, 011328600200550
011328600200556, 011328600200557, 011328600200558, 011328600200559, 011328600200560
011328600200566, 01132860
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 2
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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