FDAFDA · Alimentos y medicamentos·N.º oficial Z-0749-2018
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Publicado el 7 de marzo de 2018 · Inicio del retiro: 15 de junio de 2017
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
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Steris Corporation
- Distribuidor
- US Nationwide Distribution
- Lote
- Model# 883048 Lot# 161116A
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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