IsoFlex LAL Support Surface recalled over fire hazard

Recall date

August 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Medical Division of Stryker Corporation recalls IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the preventi…

Recall number

Z-3181-2018

FDA classification

Class II

Brand / firm

Stryker Medical Division of Stryker Corporation

Sold / distributed

US Nationwide in the states of: KY, NH, OH, PA, and TX.

Why it was recalled

Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 to: be 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.