FDAFDA · Alimentos y medicamentos·N.º oficial Z-2015-2012
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Publicado el 25 de julio de 2012 · Inicio del retiro: 12 de junio 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
GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide Distribution -- USA (nationwide) including the states of AK, CA, IL, MS, NJ, PR, SD, TN, TX, and VA. and the countries of ARGENTIAN, AUSTRALIA, BELGIUM, CHINA, GERMANY, ALGERIA, ECUADOR, EGYPT, FINLAND, UNITED KINGDOM, JORDAN, JAPAN, MOROCCO, MAURITUS, NETHERLANDS, OMAN, PERU, SEBIA, SUDI ARABIA, SINGAPORE, EL SALVADOR, TURKEY, URUGUAY and SOUTH AFRICA.
- Lote
- Product ID Number Lot Code 2016995-001 xxxx2010E 2016995-002 xxxx2010D 2016995-003 xxxx2010C 2016995-004 xxxx2010C
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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