FDAFDA · Alimentos y medicamentos·N.º oficial Z-2259-2024
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/functions. Catalog Number: 0408-800-000NS
Publicado el 10 de julio de 2024 · Inicio del retiro: 3 de junio de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Expired Products distributed to customers
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Corporation
- Distribuidor
- US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
- Lote
- GTIN: 07613327514063 Lot Number: 20040649
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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