FDAFDA · Alimentos y medicamentos·N.º oficial Z-2332-2017
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Publicado el 21 de junio de 2017 · Inicio del retiro: 9 de mayo 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
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Arrow International Inc
- Distribuidor
- Worldwide Distribution - US (nationwide) and Canada
- Lote
- Material number: ASK-45703-AH, CDC-42703-1A, CDC-42703-1A, CDC-42854-1A, CDC-45703-1A, CDC-45703-A1A, CDC-45703-B1A, CDC-45854-1A, CDC-47702-1A Device Listing D213817
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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