MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-3114-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e) BRONCH LAB PACK-LF, Pack Number DYNJ24810B; f) THORACIC, Pack Number DYNJ907991F; g) RECTAL, Pack Number DYNJ908108A; h) ROBOTIC, Pack Number DYNJ908109C; i) CERVICAL, Pack Number DYNJ908748D; j) LAMI, Pack Number DYNJ908750D; k) MERCY TIFFIN BASIC-LF, Pack Number DYNJ909731; l) MERCY TIFFIN LITHOTOMY, Pack Number DYNJ909735; m) BASIC GENERAL SET UP, Pack Number DYNJ909945; n) BASIC GENERAL SET UP, Pack Number DYNJ909945A; o) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289; p) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289H; q) MTHZ TOTAL HIP, Pack Number DYNJC9311M; r) BRONCH KIT, Pack Number P906877
Class II
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.
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/DI case 40195327618675, UDI/DI each10195327618674, Lot Numbers: 24CBC847; p) DYNJ910289H: UDI/DI case 40198459012489, UDI/DI each10198459012488, Lot Numbers: 24CBC847; q) DYNJC9311M: UDI/DI case 40198459012489, UDI/DI each10198459012488, Lot Numbers: 24FDA111; r) P906877: UDI/DI case 40889942002581, UDI/DI each10889942002580, Lot Numbers: 24FDA021
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Voluntary: Firm initiated