MEDLINE INDUSTRIES, LP - Northfield: 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-SECTI

Hazard

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

Details from the source

Reason for recall: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands. Quantity: 1098 units 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

UPC codes

10653160994244, 40653160994245, 10195327103620, 40195327103621, 10889942686810, 40889942686811, 10888277988514, 40888277988515, 10193489776713, 40193489776714, 10193489852370, 40193489852371, 10889942532803, 40889942532804, 10889942671779, 40889942671770, 10195327273071, 40195327273072, 10195327248383, 40195327248384

Source

Official record: FDA (Device enforcement) ↗

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