FDA recall Z-3015-2020

Stryker Medical Division of Stryker Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution including in the states of CA, FL, NY, OH.

Key facts

Status: Terminated
Initiation date: 2020-08-12
Report date: 2020-10-07
Termination date: 2021-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

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