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Terminated

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.

FDA Recall Z-3181-2018 · Posted None

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeIOQ
Date Initiated2018-08-13
Date Terminated2020-05-21
Product Quantity243

Reason for Recall

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

Firm Action

Urgent Medical Device Correction notification letters dated 8/13/18 were distributed to customers. The letters included the following instructions: 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email [email protected]. 3. Upon receipt of the completed business reply form, a member of Strykers field service personnel will contact you to arrange for the replacement of the fire barrier on your affected IsoFlex LAL units. 4. If you have questions regarding the continued safe use of your products, please contact Technical Support by calling +1 800 327 0770 and selecting opt 2. 5. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers in the space provided on the business reply form.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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