FDAFDA · Alimentos y medicamentos·N.º oficial Z-1732-2013
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Publicado el 24 de julio de 2013 · Inicio del retiro: 27 de febrero de 2013
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
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Terumo Cardiovascular Systems Corporation
- Distribuidor
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
- Lote
- Catalog number: 500AV* and serial numbers: 0024, 0033, 0040, 0051, 1192, 1193, 1355,1356, 1420, 1423, 1464, 1465, 1467, 1468,1483,1504,1521-1524,1526,1527,1529,1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901,2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, 5578, and 5579.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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