Recall Z-3015-2020 ยท IKY Mattress, Flotation Therapy, Non-Powered
Stryker Medical Division of Stryker Corporation
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
| Date | Aug 12, 2020 |
| Status | Terminated |
| Reason | Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR |
| Root cause | Nonconforming Material/Component |
| Action | Stryker issued Medical Device Correction Notice dated 8/12/20, initially in person or via email by a Stryker Sales Representative with the customer notification letter. Letter states reason for recall, health risk, action to take: 1. Locate the units listed on the attached business reply form and remove them from use until they can be corrected. 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, Stryker will contact you to arrange for the correction |
| Quantity | 110 units |
| Distribution | US Nationwide distribution including in the states of CA, FL, NY, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.