medical Class II Updated 2025-04-23

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) ED

Recalled Product

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281

Hazard / Issue

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1) MNS13635A, UDI-DI: 10653160994244(each), 40653160994245(case), Lot Number: 24IBH747; 2) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM309; 3) OBK387M, UDI-DI: 10889942686810(each), 40889942686811(case), Lot Number: 24JBM385; 4) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM576; 5) DYNJ40573A, UDI-DI: 10888277988514(each), 40888277988515(case), Lot Number: 24JBM871; 6) CDS983998C, UDI-DI: 10193489776713(each), 40193489776714(case), Lot Number: 24JBS915; 7) DYNJ64300A, UDI-DI: 10193489852370(each), 40193489852371(case), Lot Number: 24JBU461; 8) DYNJ55205, UDI-DI: 10889942532803(each), 40889942532804(case), Lot Number: 24JBV449; 9) DYNJ56550, UDI-DI: 10889942671779(each), 40889942671770(case), Lot Number: 24JBV561; 10) DYNJ83507, UDI-DI: 10195327273071(each), 40195327273072(case), Lot Number: 24JBX835; 11) DYNJ83248, UDI-DI: 10195327248383(each), 40195327248384(case), Lot Number: 24KBF051; 12) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24KBG874

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