Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.
Publicado el 18 de marzo de 2020 · Inicio del retiro: 19 de enero de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- EHOB, Inc.
- Distribuidor
- US Nationwide distribution in the state of TX.
- Lote
- Master Lot # 932213A, Product Lot Code 932243A
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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