FDAFDA · Alimentos y medicamentos·N.º oficial Z-2385-2018
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).
Publicado el 18 de julio de 2018 · Inicio del retiro: 17 de mayo de 2018
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
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Arrow International Inc
- Distribuidor
- US Nationwide Distribution in the states of AR, AZ, CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TX, VA & WA
- Lote
- Lot Number: 13F16M0102
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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