FDAFDA · Alimentos y medicamentos·N.º oficial Z-1433-2020
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Publicado el 11 de marzo de 2020 · Inicio del retiro: 3 de enero de 2020
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
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Bard Peripheral Vascular Inc
- Distribuidor
- Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
- Lote
- Lot number VTCW0468; UDI number (01)00801741086304(17)200901(10)VTCW0468.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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