Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pa...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3015-2020.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3015-2020.
Recall terminated by FDA.
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- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3015-2020.
Stryker Medical Division of Stryker Corporation
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Stryker Medical Division Of Stryker Corporation Recall FAQ
Stryker Medical Division Of Stryker Corporation is the subject of a medical devices safety report: Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pa.... The notice was published on August 12, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 110 units are potentially affected.