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FDA (Device enforcement)Recalled 2024-06-27class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ90810

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: 350 units Lot/code info: a) DYNJ908104B: UDI/DI case 40195327507115, UDI/DI each 10195327507114, Lot Numbers: 23LBT869, 24BBQ730; b) DYNJ908106B: UDI/DI case 40195327507139, UDI/DI each 10195327507138, Lot Numbers: 24ABB087, 24CBM739, 24EBH234; c) DYNJ909946: UDI/DI case 40195327512652, UDI/DI each 10195327512651, Lot Numbers: 23LBD934, 24DBB806; d) DYNJ909951: UDI/DI case 40195327512904, UDI/DI each 10195327512903, Lot Numbers: 23LBD932, 24ABP740

UPC codes

40195327507115, 10195327507114, 40195327507139, 10195327507138, 40195327512652, 10195327512651, 40195327512904, 10195327512903

Source

Official record: FDA (Device enforcement)

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

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