FDA-Device2020-10-07Class II

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

Stryker Medical Division of Stryker Corporation
Hazard

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

Sold states
US Nationwide distribution including in the states of CA, FL, NY, OH.
Affected count
110 units
Manufactured in
3800 E Centre Ave, N/A, Portage, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3015-2020

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