Z-0596-2025 Class II Ongoing

Recalled by Becton Dickinson & Co. — Sparks, MD

Recall Details

Product Type
Devices
Report Date
December 11, 2024
Initiation Date
October 31, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
584 units (313 US, 271 OUS)

Product Description

BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475

Reason for Recall

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.

Distribution Pattern

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.

Code Information

Catalog No: 445475; UDI-DI: 00382904454753; Serial Numbers: DB5631, DB 6970, DB6857, DB6859, DB6122, DB3043, MD1710, DB4372, DB6043, DB2249, DB5030, DB2882, DB3090, MD2046, DB4927, DB5825, DB2828, DB2835, DB3251, DB3245, DB6893, DB3145, DB3211, DB5876, DB5906, DB4284, DB5948, DB3143, DB3204, DB6891, PM4385R, DB5761, DB4811, DB4718, DB3231, DB2786, DB4793, DB2322, DB6522, DB4820, DB2216, DB6558, DB4113, DB5168, DB2544, DB6674, DB4263, DB4842, DB6369, DB6900, DB4828, DB4418, DB5204, DB5282, DB4286, DB5569, DB5626, FS1472, FS1473, FS1230, FS1234, DB2702, DB4367, DB6655, DB6920, DB4365, DB2219, FT1004, DB6156, DB6961, DB2421, DB5244, DB2530, DB2844, DB4890, DB5146, DB5443, DB6011, DB5940, DB6628, DB3318, DB2417, MD1748, DB6315, DB4134, FS1320, DB3307, DB4304, MD2027, DB4152, MD1851, FS1280, DB2152, DB6243, DB4680, FS1004, FS1094, FS1001, DB6570, DB6391, DB6393, DB3004, DB4706, DB4248, DB6392, DB4260, DB6573, DB6571, DB2840, DB6584, DB2974, DB6634, DB4267, DB4440, DB2548, DB4449, DB6491, DB6903, DB4892, DB5529, DB2925, DB6595, DB5538, DB4271, DB6936, DB4987, DB2337, DB3389, DB3340, DF1540, DB2332, DB7013, DB4492, FS1178, FS1519, DB4565, DB4589, DB4028, DB6430, DB3076, DB6258, MD1730, MD1810, DB4586, DB5340, DB6499, DB5347A, DB5398, DB6603, MD2086, DB6113, DB2884, DB4733, DB4739, DB2804, DB4631, DB2276, DB4506, DB3024, DB6123, DB6590, DB4557, DB6281, 94707, DB6426, DB6657, DB6933, DB6658, DB4936, DB6324, DB2561, DB5865, DB5163, DB5005, DB6745, DB5200, DB5878, DB6709, DB4869, DB6058, DB6646, DB6645, DB6843, DB5094, DB4917, DB6845, DB6863, DB7074, DB7003, DB7071, DB7004, DB6994, DB7041, DB7133, DB7132, DB7167, DB6755, DB7187, DB7144, DB7142, DB6451, DB6689, DB7199, DB7182, DB7203, DB7136, DB5880, DB6896, DB6464, DB6679, FS1426, MD1634, DB1679, DB7050, DB6342, DB6872, DB2657, DB6576, DB6719, DB6938, DB4377, DB7000, DB6733, FS1400, DB2556, MD1750, DB6237, DB5602, DB7007, DB7008, DB6883, DF1563, DB6950, DB6559, DB6951, DF1562, DB6918, DB5858, DB5350, DB6041, DB4998, DB6484, DB6505, DB5363, DB6792, DB7212, DB5381, DB5422, DB5682, DB5653, DB5429, DB5784, FS1494, DB2516, DB4662, DB4665, MD1793, MD1794, DB4763, DB6809, MD1916, DB5905, MD1610, MD1840, DB2160, DB7178, DB6302, DB6165, MD1925, MD2056, MD2122, DB5596, DB5919, DB5861, DB5862, DB5813, DB5937, DB5089, DB6034, DB2403, MD1619, DB7157, DB2453, DB2424, DB5215, DB1059, DB2238, DB4020, DB5740, DB5065, DB6858, DB5955, DB2244, DB5021, DB3086, DB4776, 97R4YC2, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB5491, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, DB3279, DB3349, DB4149, DB 5844, DB 5845, DB5847, DB 5997, DB 5846, DB5888, DB5683, DB4805, DB6802, DF1547, DB6218, DB6685, RC1164, DB2212, DB3212, DB4868, DB4891, DB4478, DB4742, DB5096, DB4855, DB6262, DB5668, DB2384, DB6024, DB6071, DB7101, DB7098, DB7100, DB6018, DB6036, DB2939, DB2967, DB5286, DB2146, FS1073, DB7120, DB5522, DB2977, DB6096, DB6483, DB6604, DB6640, DB6750, DB6670, DB6814, DB6815, DB7099, DB6990, DB7122, DB7110, DB6736, DB7139, DB7140, DB7190, DB7180, DB7191, DB7194, DB7216, DB7204, DB7205, DB7197, DB7173, DB2312, DB6597, DB5077, DB3291, DB4538, DB6155, DB6485, DB6486, DB6487, DB6488, DB7062, DB7185, DB4344, DB4453, DB4952, MD1771, MD1877, DB4138, DB6142, DB6477, MD1847, FS1470, FS1476, DB5084, FS1244, MD2047, DB5302, DB7030, DB2170, DB4816, DB5620, DB5169, DB5507, DB5737, DB5202, DB6811, DB7034, DB2220, DB5525, DB2221, DB6715, DB6708, DB6734, DB6781, DB2588, DB6780, DB7054, DB6268, DB2204, DB5696, DB6403, DB2737, DB5643, DB6717, DB2660, DB6591, DB6911, DB2633, DB5743, DB6852, DB2357, DB2758, DF1552, DB6790, TBD1234, DB6786, DB6323, DB6996, DB6941, DB6850, DB6907, DB6980, DB6952, DB5449, DB5375, DB5373, DB7076, DB4234, DB5608, DB5407, DB5652, DB5430, DB5512, DB4550, DB5594, DB7097, DB6213, DB5550, MD1832, DB2493, DB5083, MD1917, DB5734, DB7175, DB5911, DB5756, DB7176, DB7179, DB5800, DB5914, MD1611, DB2705, DB2377, MD1615, DB2378, DB6032, DB6054, DB6861, DB6494, DB4055, DB2845, DB6357, DB4083, DB4225, DB6121, DB4635, DB4078, DB6383, DB6671, DB6381, DB2819, DB3154, FS1011, DB2966, FS1193, DB6532, DB2818, DB6291, DB6283, MD1791, DB6617, DB6457, DB3124, DB4835, DB6169, DB4682, DB4596, DB6212, DB4649, DB4366, DB7096, DB6929, DB6978, DB6913, DB6319, FS1485, FS1341, DB2178, DB2619, FS1270, DB6240, MD1690, DB6317, DB6239, DB6300, DB4872, DB4441, DB2998, DB6581, DB6540, DB4451, DB6635, DB6699, DB2335, FS1461, DB6160, FS1204, DB5325, DB6161, FS1520, DB4206, DB4024, DB4765, FS1419, DF1596, MD1624, DB4619, DB6242, DB6496, DB4321, DB6331, DB6241, DB6667, DB4759, DB4322, DB4326, DB4752, DB4338, DB6339, DB3054, DB6989, DB4594, DB4938, DB4939, DB7022, DB7023, DB5177, DB5232, DB5205, DB5242, DB5274, DB7040, DB6905, DB2163, DB6065, DB6993, DB2620,