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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE

Hazard

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Details from the source

Reason for recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. Distribution: Worldwide distribution. Lot/code info: 81239, Lot Number 24DDA646; 81239, Lot Number 24BDA159; 81239, Lot Number 24ADA118; 81239, Lot Number 23LDB385; 81239, Lot Number 23FDB922; 81239, Lot Number 23FDB435; 81239, Lot Number 23CDC570; 81239, Lot Number 23BDA790; 81239, Lot Number 23ADA161; 81239, Lot Number 22LDA211; 81239, Lot Number 22KDA441; 81239, Lot Number 22HDA985; 81239, Lot Number 22GDB017; 81239, Lot Number 22FDA642; 81239, Lot Number 22BDB971; 81239, Lot Number 22BDB067; 81239, Lot Number 22BDA725; 81239, Lot Number 21LDA117; 81239, Lot Number 21KDB172; 81239, Lot Number 21HDA966; 81239, Lot Number 21GDD227; 81239, Lot Number 21DDC268; 81239, Lot Number 21DDA425; 81239, Lot Number 21CDB386; 81239, Lot Number 21BDB285; 81239, Lot Number 21ADA073; 946279 , Lot Number 21BKA450 ; ART1165, Lot Number 2022081890; ART1165, Lot Number 2022111890; ART1165, Lot Number 2023071190; ART1165, Lot Number 2023083190; ART1165, Lot Number 2023092290; ART1165, Lot Number 2023110990; ART1165, Lot Number 2023122990; ART1165, Lot Number 2024031290; ART1210, Lot Number 2023080190; ART240B, Lot Number 2023112290; ART240B, Lot Number 2024031590; ART960A, Lot Number 2023082890; ART960A, Lot Number 2023092790; ART960A, Lot Number 2023112990; ART960A, Lot Number 2023122190; ART960A, Lot Number 2024020190; ART970A, Lot Number 2023082890; ART970A, Lot Number 2023120790; BT1015, Lot Number 2019031190; BT1015, Lot Number 2021030190; BT1015, Lot Number 2022030490; BT1060, Lot Number 2020010790; BT1060 , Lot Number 21HBS949 ; BT1060 , L

Source

Official record: FDA (Device enforcement)

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

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