Recall Z-3181-2018 ยท IOQ Bed, Flotation Therapy, Powered
Stryker Medical Division of Stryker Corporation
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 su
| Date | Aug 13, 2018 |
| Status | Terminated |
| Reason | Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. |
| Root cause | 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 IsoFle |
| Quantity | 243 |
| Distribution | US Nationwide in the states of: KY, NH, OH, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.