PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398),
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling approximately 5.3 million PowerLoc MAX Power Injectable Infusion Sets worldwide due to a potential defect in the tubing near the Luer or Y site. The affected devices may develop cracks or breaks in the tubing that could cause leakage of medications, chemotherapy drugs, or blood. The recalled units are identified by multiple catalog numbers (0131910, 0131915, 0131975, 0132010, and others) and specific lot numbers, which are listed in the recall notice.
If the tubing cracks or breaks, patients could experience blood loss, blocked catheters, air embolism (air entering the bloodstream), interrupted medication delivery, or contamination at the infusion site that may lead to infection. The source document does not specify what affected consumers should do in response to this recall.
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 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801741047466), 0142210 (UDI 00801741047473), 0142215 (UDI 00801741047480), 0142275 (UDI 00801741047497). Lot Numbers: ASCXF007 ASCXF019 ASDRF074 ASDRF075 ASDRF079 ASDRF084 ASDVF021 ASCXF001 ASDNF040 ASDNF043 ASDVF031 ASDWF118 ASCXF006 ASCXF018 ASDRF053 ASDRF058 ASDRF060 ASDRF071 ASDVF029 ASDWF117 ASCYF028 ASCYF029 ASCZF025 ASDPF029 ASDQF015 ASDQF039 ASDQF041 ASDRF065 ASDTF043 ASDTF054 ASDTF055 ASDTF061 ASDVF018 ASCYF023 ASCYF024 ASDTF031 ASDTF032 ASDTF033 ASDTF037 ASDTF038 ASCYF040 ASCYF076 ASCZF055 ASDNF001 ASDNF002 ASDNF004 ASDNF018 ASDQF036 ASDTF075 ASDTF096 ASDTF104 ASDTF105 ASDTF115 ASDUF006 ASDUF019 ASDUF026 ASDUF033 ASDUF042 ASDUF059 ASDUF063 ASDUF078 ASDUF097 ASDUF102 ASDUF105 ASDUF111 ASDUF119 ASDVF005 ASDVF014 ASDWF070 ASDWF081 ASDWF086 ASDWF102 ASDWF114 ASDTF023 ASDTF024 ASDTF025 ASDTF034 ASDTF035 ASCYF020 ASDTF027 ASDTF028 ASDTF036 ASCYF021 ASCYF022 ASDTF016 ASDTF017 ASDTF018 ASDTF019 ASDWF106 ASCXF009 ASCXF010 ASDRF088 ASDRF089 ASDRF092 ASDRF095 ASDRF096 ASDXF071 ASDXF073 ASENF043 ASENF047 ASENF048 ASCXF002 ASDNF042 ASDX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.