MEDLINE INDUSTRIES, LP - Northfield: Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1

Hazard

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.

Details from the source

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: 3117 units Lot/code info: a) DYKE1092B: UDI/DI case 40889942777366, UDI/DI each10889942777365, Lot Numbers: 24BBK418, 24DBH210; b) DYKE1666: UDI/DI case 40193489708487, UDI/DI each10193489708486, Lot Numbers: 24ADB503, 24CDA282, 24CDB279, 24DDB221, 24EDA406; c) DYKM2196: UDI/DI case 40195327236916, UDI/DI each10195327236915, Lot Numbers: 23LBF762, 24BBB541, 24CBI973, 24DBH448; d) DYKM2196H: UDI/DI case 40195327236916, UDI/DI each10195327236915, Lot Numbers: 23LBF762, 24BBB541, 24CBI973, 24DBH448; e) DYNJ24810B: UDI/DI case 40889942440611, UDI/DI each10889942440610, Lot Numbers: 24CBE214; f) DYNJ907991F: UDI/DI case 40195327641468, UDI/DI each10195327641467, Lot Numbers: 24DLA042, 24DLA594; g) DYNJ908108A: UDI/DI case 40195327507153, UDI/DI each10195327507152, Lot Numbers: 24BBK532; h) DYNJ908109C: UDI/DI case 40195327507238, UDI/DI each10195327507237, Lot Numbers: 23LBT867, 24BBA187, 24DBI723, 24FBA058; i) DYNJ908748D: UDI/DI case 40195327549207, UDI/DI each10195327549206, Lot Numbers: 23LBE394, 24CBD863; j) DYNJ908750D: UDI/DI case 40195327549214, UDI/DI each10195327549213, Lot Numbers: 24FBC284; k) DYNJ909731: UDI/DI case 40195327464524, UDI/DI each10195327464523, Lot Numbers: 24ABU492; l) DYNJ909735: UDI/DI case 40195327464685, UDI/DI each10195327464684, Lot Numbers: 23LBH989, 24ABV099, 24CBG700; m) DYNJ909945: UDI/DI case 40195327512669, UDI/DI each10195327512668, Lot Numbers: 24ABV895; n) DYNJ909945A: UDI/DI case 40195327615803, UDI/DI each10195327615802, Lot Numbers: 24DBA530; o) DYNJ910289: UDI

UPC codes

40889942777366, 40193489708487, 40195327236916, 40889942440611, 40195327641468, 40195327507153, 40195327507238, 40195327549207, 40195327549214, 40195327464524, 40195327464685, 40195327512669, 40195327615803, 40195327618675, 40198459012489, 40889942002581

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.