Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Reason for recall: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama. Quantity: 29,585 units Lot/code info: a) DYNJAA0311C: UDI/DI case: 40193489343510, UDI/DI each 10193489343519, Lot Numbers: 24DBV950, 24CBL800, 24BBI902, 23LBT319; b) DYNJAA0323C: UDI/DI case 40195327423699, UDI/DI each 10195327423698, Lot Numbers: 24DBM735, 24DBN216, 24CBI422, 24CBJ132, 23KBU156; c) DYNJAA0378A: UDI/DI case 40195327450046, UDI/DI each 10195327450045, Lot Numbers: 24DBQ840, 24DBQ839, 24DBB513, 24ABM732, 24ABU331, 24ABU330, 24ABQ036, 24ABK802, 24ABF565, 24ABG771, 23LBN692, 23LBL609, 23KBU727; d) DYNJAA10579: UDI/DI casev40889942600749, UDI/DI unit 10889942600748, Lot Numbers: 23LBL288; e) DYNJAAF6674I: UDI/DI case 40195327381623, UDI/DI each 10195327381622, Lot Numbers: 24DBM458, 24CBS798, 24CBO294, 23LBV673
40193489343510, 10193489343519, 40195327423699, 10195327423698, 40195327450046, 10195327450045, 10889942600748, 40195327381623, 10195327381622
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.