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FDA (Device enforcement)Recalled 2025-03-03class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S

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: 530 units Lot/code info: 1) DYNJ59620A, UDI-DI: 10193489685367(each), 40193489685368(case), Lot Number: 24KBH321; 2) DYND150200S, UDI-DI: 10195327387884(each), 40195327387885(case), Lot Number: 24KBK308

UPC codes

10193489685367, 40193489685368, 10195327387884, 40195327387885

Source

Official record: FDA (Device enforcement)

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

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