SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 0080174108
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling SafeStep Huber Needle Set Port Access Kits due to potential cracks or breaks that can develop in the tubing near the Luer or Y site of the device. When cracks or breaks occur, they can cause leakage that exposes patients to chemicals such as chemotherapy drugs or biohazardous materials like blood. Approximately 5.3 million units with various catalog numbers and lot numbers have been distributed worldwide.
If tubing cracks or breaks develop, patients may experience blood loss, catheter occlusion, air embolism, inadequate or interrupted infusion, or contamination at the infusion site that could lead to infection. The recall notice does not specify a remedy or recommended action for 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 PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635). Lot Numbers: REDX2834 REDX4856 REDY1792 REDY2773 REEN2075 REEN4559 REEP1004 REEP3058 REEQ4021 REER0466 REER1235 REER2399 REDW3688 REDZ3026 REEN1109 REEP2916 REEQ2690 REEQ4063 REDS1399 REDS1875 REDS3371 REDS4425 REDT1836 REDU4512 REDX2861 REDY0778 REDY3542 REDZ3102 REEN1044 REEP3066 REEQ2648 REER2400 REDR1897 REDR2695 REDR2796 REDS1288 REDS1400 REDS2408 REDS4621 REDT0697 REDT1645 REDT1837 REDT2924 REDT4207 REDU2262 REDU2347 REDU3328 REDV1094 REDV1239 REDV2772 REDV2983 REDW0413 REDX3752 REDY1723 REDY3731 REDZ0146 REDZ1859 REDZ3027 REEN2076 REEN2144 REEN3136 REEP0964 REER2366 REER2367 REER2401 REDN3937 REDQ0732 REDQ1532 REDQ3957 REDS1850 REDS2265 REDT0698 REDT1646 REDT2747 REDT4188 REDU0781 REDU2263 REDV2200 REDV3476 REDW0549 REDX1497 REDX3753 REDZ1056 REDZ1761 REEN1110 REEN2794 REEN4560 REEP3956 REDY3732 REDZ1860 REEN2774 REEN4491 REEP1005 REEQ1672 REER1236 REDQ1535 REDR2696 REDR2795 REDS1857 REDS4422 REDT1838 REDT2744 REDZ1762 REEN1045 REEN2786 REEN4561 REEP2919 REEP4051 REEQ4065 REER1273 REDX0146 REDY0779
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.