medical Class II Updated 2018-09-26

Stryker Medical Division of Stryker Corporation recalls IsoFlex LAL Support Surface, Model Number 2860 Product Us

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 201803286019000540 201803286019000541 201803286019000552 201803286019000553 201803286019000562 201803286019000563 201803286019000564 201803286019000565 201803286019000566 201803286019000572 201803286019000573 201803286019000574 201803286019000575 201803286019000576 201803286019000577 201803286019000578 201803286019000579 201803286019000580 201803286019000581 201803286019000585 201803286019000595 201803286019000600 201803286019000602 201803286019000603 201803286019000605 201803286019000619 201803286019000620 201803286019000662 201803286019000663 201803286019000664 201803286019000667 201803286019000668 201803286019000669 201803286019000670 201803286019000710 201803286019000512 201803286019000515 201803286019000516 201803286019000521 201803286019000555 201803286019000567 201803286019000568 201803286019000588 201803286019000589 201803286019000590 201803286019000591 201803286019000001 201803286019000002 201803286019000003 201803286019000004 201803286019000005 201803286019000503 201803286019000504 201803286019000505 201803286019000506 201803286019000507 201803286019000508 201803286019000517 201803286019000518 201803286019000519 201803286019000520 201803286019000522 201803286019000532 201803286019000533 201803286019000534 201803286019000535 201803286019000536 201803286019000537 201803286019000538 201803286019000539 201803286019000557 201803286019000558 201803286019000559 201803286019000560 201803286019000561 201803286019000592 201803286019000593 201803286019000594 201803286019000596 201803286019000597 201803286019000598 201803286019000599 201803286019000604 201803286019000606 201803286019000607 201803286019000608 201803286019000609 201803286019000610 201803286019000611 201803286019000612 201803286019000613 201803286019000614 201803286019000615 201803286019000616 201803286019000617 201803286019000618 201803286019000621 201803286019000622 201803286019000623 201803286019000624 201803286019000625 201803286019000626 201803286019000627 201803286019000628 201803286019000629 201803286019000630 201803286019000631 201803286019000632 201803286019000633 201803286019000634 201803286019000635 201803286019000636 201803286019000637 201803286019000638 201803286019000639 201803286019000640 201803286019000641 201803286019000642 201803286019000643 201803286019000644 201803286019000645 201803286019000646 201803286019000647 201803286019000648 201803286019000649 201803286019000650 201803286019000651 201803286019000652 201803286019000653 201803286019000654 201803286019000655 201803286019000656 201803286019000683 201803286019000684 201803286019000685 201803286019000687 201803286019000688 201803286019000690 201803286019000691 201803286019000692 201803286019000697 201803286019000698 201803286019000699 201803286019000700 201803286019000701 201803286019000702 201803286019000703 201803286019000704 201803286019000706 201803286019000707 201803286019000708 201803286019000709 201803286019000711 201803286019000797 201803286019000798 201803286019000799 201803286019000800 201803286019000801 201803286019000802 201803286019000803 201803286019000804 201803286019000805 201803286019000806 201803286019000671 201803286019000712 201803286019000722 201803286019000723 201803286019000724 201803286019000725 201803286019000726 201802286019000351 201802286019000364 201803286019001048 201803286019001049 201803286019001052 201803286019001065 201803286019001066 201803286019001067 201803286019001074 201803286019001075 201803286019001077 201803286019001111 201803286019001160 201803286019001165 201802286019000222 201802286019000274 201802286019000377 201802286019000402 201802286019000403 201802286019000405 201802286019000468 201802286019000469 201802286019000470 201802286019000475 201802286019000482 201802286019000483 201802286019000486 201802286019000489 201802286019000500 201803286019000528 201801286019000030 201801286019000034 201801286019000106 201801286019000109 201801286019000110 201801286019000131 201801286019000132 201801286019000133 201802286019000161 201802286019000162 201802286019000163 201802286019000164 201802286019000165 201802286019000191 201802286019000192 201802286019000251 201802286019000252 201802286019000315 201802286019000376 201802286019000378 201802286019000391 201802286019000398 201802286019000404 201802286019000407 201802286019000408 201802286019000409 201802286019000410 201802286019000411 201802286019000412 201802286019000413 201802286019000414 201802286019000415 201802286019000420 201802286019000423 201802286019000424 201802286019000425 201802286019000433 201802286019000449 201802286019000450 201802286019000451 201801286019000220 201802286019000177 201802286019000462
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