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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0589-2025

BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990

Publicado el 11 de diciembre de 2024 · Inicio del retiro: 31 de octubre de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Becton Dickinson & Co.
Distribuidor
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.
Lote
Catalog No: 443990; UDI-DI: 00382904439903; Serial Numbers: CRG0023, CRG0041, CRG0115, CRG0040, CRG0106, CRG0110, CRG0112, CRG0109, CRG0047, CRG0120, CRG0039, CRG0113, CRG0035, CRG0037, CRG0036, VGT0009, CRG0020, CRG0002, VGX0004, CRG0007, CRG0008, CRG0104, CRG0018, CRG0019, CRG0045, CRG0029, CRG0028, CRG0030, CRG0201, CRG0203, CRG0021, CRG0004, CRG0005, CRG0006, CRG0009, CRG0010, CRG0012, CRG0011, CRG0013, CRG0014, CRG0025, CRG0015, CRG0016, CRG0017, CRG0026, CRG0027, CRG0107, CRG0101, CRG0105, CRG0108, CRG0114, CRG0116, CRG0117, CRG0119, CRG0118, CRG0034, CRG0044, CRG0001, CRG0003, CRG0032, CRG0038, CRG0043, CRG0042, CRG0102, CRG0111, CRG0048, CRG0103, CRG0121, CRG0204, CRG0207,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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