FDAFDA · Alimentos y medicamentos·N.º oficial Z-1660-2013
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
Publicado el 10 de julio de 2013 · Inicio del retiro: 21 de noviembre de 2012
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
Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Merit Medical Systems, Inc.
- Distribuidor
- U.S. Military Hospital on base in Landstuhl, Germany
- Lote
- Merit's Custom Angio kits K09T-09812B and K09T-09812C, Lot numbers T252244, T318352, T342249, T359185
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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