PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
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 Set AllPoints Port Access System devices worldwide due to a potential defect in the tubing near the Luer or Y site. The affected devices carry catalog numbers AN132075, AN142010, AN142010G, or AN142075, along with specific lot numbers listed in the recall notice.
The tubing in affected devices may develop cracks or breaks that can cause leakage of chemotherapy drugs, blood, or other biohazardous materials. This leakage could result in serious complications including blood loss, catheter blockage, air embolism, interrupted infusion, or infection at the injection site. The recall notice does not specify what action affected consumers should take.
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 AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224). Lot Numbers: REDT4257 REDV3617 REDY1815 REDY2789 REDZ0385 REEN2192 REEN2782 REDW2682 REDX1471 REDX3857 REDY0765 REDY1593 REDY2943 REDZ0676 REDZ1903 REDZ3077 REEN1222 REEN3292 REEP0666 REEP4137 REER0612 REDW1021 REDX1360 REDX4728 REDY1816 REDY2935 REDY3765 REDZ1825 REDZ3146 REEN1935 REEP0773 REEP3544 REEP4066 REER0579 REER1103 REDV2172 REDV3683 REDW0467 REDW0521 REDW1023 REDW1157 REDX1361 REDX1490 REDY0815 REDY1594 REDY2790 REDY3544 REDZ0110 REDZ0386 REDZ0677 REDZ1904 REDZ3078 REEN1072 REEN2186 REEN3075 REEN3310 REEP0663 REEP1401 REEP4138 REEQ0611 REEQ1246 REEQ2436 REEQ3589 REER0576 REER1046 REER2161 Additional lot added 10/16/20: REEU0314
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.