SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 00801741066306), LH-0037 (UDI 0080
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling SafeStep Huber Needle Sets across multiple catalog numbers (LH-0029 through LH-0040) distributed worldwide due to the potential development of cracks or breaks in the tubing near the Luer or Y site. Approximately 5.3 million units are affected across numerous lot numbers. When cracks or breaks develop, they can cause leakage that exposes patients to hazardous materials including chemotherapeutics and biohazard materials such as blood.
Devices with cracks or breaks can result in serious complications including blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination leading to infection. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Reason for recall: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection. Distribution: Worldwide Distribution Quantity: 5,296,132 total Lot/code info: Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 00801741066306), LH-0037 (UDI 00801741066320), LH-0038 (UDI 00801741066344), LH-0039 (UDI 00801741066368), LH-0040 (UDI 00801741066382). Lot Numbers: ASCYF001 ASCYF017 ASDRF018 ASDRF031 ASDRF040 ASDSF065 ASDSF070 ASDTF004 ASDTF007 ASDVF048 ASDVF054 ASDXF058 ASDXF060 ASDXF066 ASDYF071 ASDYF077 ASDYF098 ASDZF010 ASDZF017 ASDZF024 ASDZF035 ASDZF036 ASDZF046 ASDZF071 ASDZF081 ASDZF093 ASENF002 ASERF025 ASERF032 ASCYF015 ASCYF016 ASCZF027 ASDRF043 ASDRF044 ASDRF054 ASDRF055 ASDRF056 ASDVF058 ASDVF063 ASDXF020 ASDXF045 ASENF011 ASENF014 ASERF004 ASCYF089 ASCYF090 ASCYF091 ASCYF092 ASCZF009 ASCZF010 ASCZF011 ASCZF022 ASCZF023 ASCZF039 ASCZF040 ASCZF045 ASCZF054 ASDPF016 ASDQF035 ASDQF054 ASDQF055 ASDQF060 ASDQF064 ASDRF006 ASDRF014 ASDRF019 ASDRF032 ASDRF039 ASDRF069 ASDRF073 ASDRF087 ASDRF098 ASDSF003 ASDSF010 ASDSF016 ASDSF019 ASDSF022 ASDSF033 ASDSF047 ASDSF050 ASDSF057 ASDSF061 ASDSF069 ASDTF005 ASDTF008 ASDTF022 ASDVF051 ASDVF060 ASDVF071 ASDVF079 ASDVF091 ASDWF004 ASDWF013 ASDWF018 ASDWF034 ASDWF035 ASDWF036 ASDWF040 ASDWF041 ASDWF042 ASDWF046 ASDWF047 ASDWF048 ASDWF052 ASDWF053 ASDWF054 ASDWF058 ASDWF059 ASDWF060 ASDWF080 ASDWF090 ASDWF099 ASDWF121 ASDWF126 ASDXF006 ASDXF014 ASDXF053 ASDXF063 ASDXF070 ASDXF078 ASDXF092 ASDXF096 ASDXF101 ASDX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.