FDAFDA · Food and drugs·Recall number Z-1946-2013
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Published August 21, 2013 · Recall initiated: July 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Distributor
- Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA.
- Lot
- 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 011328600100492, 011328600100493, 011328600100494, 011328600100495, 011328600100497 011328600100611, 011328600100612, 011328600100615, 011328600100617, 011328600100618 011328600100625, 011328600100626, 011328600100629, 011328600100630, 011328600100631 011328600100637, 011328600100638, 011328600100639, 011328600100640, 011328600100641 011328600100647, 011328600100648, 011328600100649, 011328600100650, 011328600100651 011328600100657, 011328600100658, 011328600100659, 011328600100660, 011328600100661 011328600100667, 011328600100668, 011328600100669, 011328600100670, 011328600100671 011328600100677, 011328600100678, 011328600100679, 011328600100680, 011328600100681 011328600100687, 011328600100688, 011328600100689, 011328600100690, 011328600100691 011328600100697, 011328600100698, 011328600100699, 011328600100700, 011328600100701 011328600100707, 011328600100708, 011328600100709, 011328600100710, 011328600100711 011328600100717, 011328600100718, 011328600100719, 011328600100720, 011328600100746 011328600100752, 011328600100753, 011328600100754, 011328600100755, 011328600100756 011328600100762, 011328600100763, 011328600100764, 011328600100765, 011328600100766 011328600100772, 011328600100773, 011328600100774, 011328600100775, 011328600100777 011328600100783, 011328600100784, 011328600100785, 011328600100786, 011328600100787 011328600100793, 011328600100794, 011328600100795, 011328600100798, 011328600100799 011328600100805, 011328600100806, 011328600100807, 011328600100808, 011328600100809 011328600100815, 011328600100816, 011328600100817, 011328600100818, 011328600100819 011328600100825, 011328600100826, 011328600100827, 011328600100828, 011328600100829 011328600100835, 011328600100836, 011328600100837, 011328600100838, 011328600100839 011328600100845, 011328600100846, 011328600100847, 011328600100848, 011328600100849 011328600100856, 011328600100857, 011328600100858, 011328600100859, 011328600100861 011328600100867, 011328600100868, 011328600100869, 011328600100870, 011328600100871 011328600100879, 011328600100880, 011328600100881, 011328600100885, 011328600100886 011328600100893, 011328600100894, 011328600100895, 011328600100896, 011328600100897 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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