SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling SafeStep Huber Needle Set AllPoints Port Access System devices distributed worldwide because the tubing near the Luer or Y site may develop cracks or breaks. The affected devices are identified by specific catalog numbers and UDI codes, and approximately 5.3 million units across numerous lot numbers are involved in this recall.
When tubing cracks or breaks occur, the device can leak and expose patients to chemicals such as chemotherapy drugs or blood and other biohazard materials. These leaks could result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination that may lead to infection. The recall notice does not specify a remedy or recommended action 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 AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439). Lot Numbers: REDT0554 REDW1158 REDW2451 REDX1491 REDY1817 REDY2798 REEN3076 REEP3245 REEP3545 REDR2659 REDS4631 REDT0709 REDT4233 REDU2308 REDV1300 REDV3619 REDX2864 REDY3766 REEP3542 REEQ0644 REER1047 REDX4729 REDZ0700 REDZ1905 REEN1900 REEN2797 REEP3240 REEP4079 REEQ0719 REEQ1251 REER1105 REEQ1250 REDR2870 REDS0199 REDS3479 REDT1592 REDU0734 REDU1349 REDU2234 REDU3360 REDU4418 REDV1066 REDV3684 REDW0388 REDW1159 REDY1595 REDY2936 REDY3545 REDZ1827 REEN2784 REEP0777 REER0610 REER2163 REDS4692 REDT0555 REDU1332 REDU2236 REDV1956 REDW3670 REDX1492 REDX3881 REDX4827 REDY1818 REDY2791 REDY3767 REDZ0388 REDZ1906 REDZ3147 REEN3311 REEQ1172 REER1106 REER2125
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.