MEDLINE INDUSTRIES, LP - Northfield: Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number D

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: 407 units Lot/code info: a) DYKE1456D: UDI/DI case 40195327639939, UDI/DI each 10195327639938, Lot Numbers: 24CBK289, 24BBK989; b) DYNJ908099B: UDI/DI case 40195327507085, UDI/DI each 10195327507084, Lot Numbers: 24DBI371, 24BBA188; c) DYNJ908101B: UDI/DI case 40195327507092, UDI/DI each 10195327507091, Lot Numbers: 24CBE408, 24BBA260, 24ABB112; d) DYNJ908105B: UDI/DI case 40195327507122, UDI/DI each 10195327507121, Lot Numbers: 24ABV362; e) DYNJ908429: UDI/DI case 40195327078820, UDI/DI each 10195327078829, Lot Numbers: 24CBB310, 23LBV007; f) DYNJ909948: UDI/DI case 40195327512911, UDI/DI each 10195327512910, Lot Numbers: 24DBD609

UPC codes

40195327639939, 10195327639938, 40195327507085, 10195327507084, 40195327507092, 10195327507091, 40195327507122, 10195327507121, 40195327078820, 10195327078829, 40195327512911, 10195327512910

Source

Official record: FDA (Device enforcement) ↗

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