Reported Aug 21, 2013 · Terminated
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Stryker Medical Division of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Medical Division of Stryker Corporation · 3800 E Centre Ave · Portage, MI · 49002-5826
Is this the product you have?
- IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
- Lot codes and dates
- Model Numbers2860-000-001
- and 2860-000-002 and serial numbers
505 of 505 codes
121228600100355121228600100356121228600100357121228600200315121228600200316 121228600200322121228600200323121228600200324121228600200325121228600200326 121228600200332121228600200333121228600200334121228600200335121228600200336 121228600200342121228600200343121228600200344121228600200345121228600200346 121228600200352121228600200353121228600200367121228600200368121228600200369 121228600200375121228600200376121228600200377121228600200378121228600200379 121228600200386121228600200393121228600200394121228600200395121228600200396 121228600200402121228600200403121228600200404121228600200405011328600100406 011328600100412011328600100413011328600100414011328600100415011328600100416 011328600100422011328600100423011328600100424011328600100425011328600100426 011328600100432011328600100433011328600100434011328600100435011328600100436 011328600100442011328600100443011328600100444011328600100445011328600100446 011328600100452011328600100453011328600100454011328600100455011328600100456 011328600100462011328600100463011328600100464011328600100465011328600100466 011328600100474011328600100475011328600100476011328600100477
- Amount recalled
- 586 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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