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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: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732

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: 35 units Lot/code info: DYNJ909732: UDI/DI case 4019532746469240195327464746, UDI/DI each 10195327464745, Lot Numbers: 23LBT911, 24ABX052, 24CBE496

UPC codes

10195327464745

Source

Official record: FDA (Device enforcement)

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

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