FDAFDA · Alimentos y medicamentos·N.º oficial Z-1344-2015
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
Publicado el 8 de abril de 2015 · Inicio del retiro: 10 de marzo de 2015
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
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Microtek Medical Inc
- Distribuidor
- US (nationwide) Distribution.
- Lote
- Lot Numbers: C9344, C10091, C10158, C10214, C10221, C10257, C10264, C10298, C10342, C11060, C11104, C11118, C11136, C11180, C11216, C11237, C11290, C11313, C11334, C12060, C12096, C12180, C12206, C12235, C12243, C12334, C12355, C13008, C13032, C13042, C13053, C13067, C13128, C13179, C13212, C13248, C13281, C13303, C13317, C13338, C14036, C14057, C14121, C14140, C14169, C14183, C14197, C14233
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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