FDAFDA · Alimentos y medicamentos·N.º oficial Z-2805-2016
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
Publicado el 21 de septiembre de 2016 · Inicio del retiro: 10 de agosto de 2016
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
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- ICU Medical, Inc.
- Distribuidor
- US Nationwide Distribution
- Lote
- Lot numbers 3273075 and 3265340.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States