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U.S. Department of Health and Human Services

Class 2 Device Recall IsoFlex LAL(R)

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  Class 2 Device Recall IsoFlex LAL(R) see related information
Date Initiated by Firm August 13, 2018
Create Date September 15, 2018
Recall Status1 Terminated 3 on May 21, 2020
Recall Number Z-3181-2018
Recall Event ID 80894
Product Classification Bed, flotation therapy, powered - Product Code IOQ
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.
Code Information 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 
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Victoria Haney
269-389-8306
Manufacturer Reason
for Recall		 Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
FDA Determined
Cause 2		 Mixed-up of materials/components
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 productfieldaction@stryker.com. 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.
Quantity in Commerce 243
Distribution US Nationwide in the states of: KY, NH, OH, PA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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