Becton Dickinson & Co.: BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Inst

Company / brand

Becton Dickinson & Co.

Product

BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.

Reason / hazard

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.

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.

Recall initiated

2025-09-23

Code info

1. Catalog Number: 44138509; UDI/DI: 00382904413859; Serial Numbers: FT5675, FT5497, FT4948, FT5781, FT5120, FT3993, FT7779, FT3387, FT1993, FT5019, FT9109, FT8412, FT7176, FT7344, FT4282, FT7400, FT6093, FT0962, FT2780, FT0795, FT0794, FT2799, FT5924, FT5279, FT5286, FT0572, FT4931, FT7289, FT9801, FT2652, FT5232, FT1348, FT8083, FT0640, FT7159, FT7034, FT8410, FT0098, FT2650, FT6203, FT3480, FT4917, FT3031, FT3033, FT4902, FT7189. 2. Catalog Number: 441676; UDI/DI: 00382904416768; Serial Numbers: FT7439A, FT7201A, FT5679, FT0599, FT0598, FT0644, FT0600, FT5025, FT2845, FT0525, FT0715, FT4439, FT0330, FT2313, FT3020, FT3022, FT0745, FT5090, FT4340, FT6225, FT4977, FT0571, FT0570, FT0498, FT5248, FT5270, FT3537, FT4448, FT3538, FT3486, FT0340, FT1517, FT5590, FT3030, FT4800, FT1774, FT2263, FT5014, FT5013, FT7184A. 3. Catalog Number: 445569; UDI/DI: 00382904455699; Serial Numbers: DB4372, DB6043, DB5030, DB5825, DB2835, DB3251, DB3245, DB3145, DB5876, DB5906, DB3143, DB3204, DB6891, PM4385R, DB4718, DB3231, DB2786, DB6628, DB6393, DB6936, DB4987, DB5347A, DB6123, DB6281, DB6933, DB6451, DB5602, DB5858, DB4763, DB6302, DB6165, DB5596, DB5089, DB7157, DB5021, DB3086, DB4776, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, RC1164, DB6323, DB4550, DB6213, DB5083, DB6383, DB6381, DB6457, DB6169, DB6212, DB6929, DB6978, DB6913, DB6540, DB6699, DB6989. 4. Catalog Number: 44229609; UDI/DI: 00382904422967; Serial Numbers: FF1979, FF0713, FF0410, FF1561, FF2832, FF4395, FF1500, FF0697, FF0933, FF1499, FF1025, FF5511, FF0027, FF1118, FF3195, FF0115, FF5979, FF6535, FF0391, FF3284, FF0772, FF0570, FF0638, FF1599, FF1271.

Product quantity

177 units

Voluntary mandated

Voluntary: Firm initiated

City

Sparks

State

MD

Country

United States

Event id

97479

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