Reported Sep 26, 2018 · Terminated
IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the…
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?
- IsoFlex LAL Support Surface
- Model Number 2860 Product Usage: The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. The patient must not exceed the safe working load as specified by the support surface. A healthcare professional should determine the use of this support surface by patients outside of the therapeutic weight range. The minimum patient age requirement for this support surface is two years. IsoFlex LAL shall be used with a support surface cover at all times. The support surface cover can interact with all external skin. This support surface is for use by patients in an acute care setting. This may include critical care, step down, progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a physician. Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors). IsoFlex
- LAL support surface is not intended tobe used in a home health environment setting be used as a sterile product include a measuring function be used with a patient less than two years of age Stryker promotes the clinical assessment of each patient and appropriate usage by the operator
- Lot codes and dates
- Serial Numbers
243 of 243 codes
201803286019000540201803286019000541201803286019000552201803286019000553201803286019000562201803286019000563201803286019000564201803286019000565201803286019000566201803286019000572201803286019000573201803286019000574201803286019000575201803286019000576201803286019000577201803286019000578201803286019000579201803286019000580201803286019000581201803286019000585201803286019000595201803286019000600201803286019000602201803286019000603201803286019000605201803286019000619201803286019000620201803286019000662201803286019000663201803286019000664201803286019000667201803286019000668201803286019000669201803286019000670201803286019000710201803286019000512201803286019000515201803286019000516201803286019000521201803286019000555201803286019000567201803286019000568201803286019000588201803286019000589201803286019000590201803286019000591201803286019000001201803286019000002201803286019000003201803286019000004201803286019000005201803286019000503201803286019000504201803286019000505201803286019000506201803286019000507201803286019000508201803286019000517201803286019000518201803286019000519
- Serial Numbers
- Amount recalled
- 243
Where it was sold
Why it was recalled
Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
This product could cause temporary or reversible health problems — stop using it.
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