Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Reason for recall: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Distribution: Worldwide distribution. Quantity: 76407 units Lot/code info: 1) Product Code/Part # 47-15-389, UDI/DI 00732094002423; Product Code/Part # 47-22-189, UDI/DI 00732094002379; Product Code/Part # 47-23-189, UDI/DI 00732094002362; Product Code/Part # 5082-01, UDI/DI 00732094113723; Product Code/Part # 5082-01H, UDI/DI 00732094113693; Product Code/Part # 5082-02, UDI/DI 00732094113679; Product Code/Part # 5082-03, UDI/DI 00732094113648; Product Code/Part # 5082-07, UDI/DI 00732094113631; Product Code/Part # 5082-08, UDI/DI 00732094113600; Product Code/Part # 5082-11, UDI/DI 00732094113327; Product Code/Part # 5082-16, UDI/DI 00732094113105; Product Code/Part # 5082-21, UDI/DI 00732094112344; Product Code/Part # 5082-22, UDI/DI 00732094112290; Product Code/Part # 5082-22H, UDI/DI 00732094112276; Product Code/Part # 5082-23, UDI/DI 00732094112245; Product Code/Part # 5082-23H, UDI/DI 00732094112221; Product Code/Part # 5082-24, UDI/DI 00732094112207; Product Code/Part # 5082-25, UDI/DI 00732094111996; Product Code/Part # 5082-26, UDI/DI 00732094111897; Product Code/Part # 5082-42, UDI/DI 00732094111873; Product Code/Part # 5082-43, UDI/DI 00732094111842; Product Code/Part # 5082-44, UDI/DI 00732094111811; Product Code/Part # 5082-45, UDI/DI 00732094111798; Product Code/Part # 5082-77, UDI/DI 00732094111644; Product Code/Part # 4500-02, UDI/DI 00732094004199; Product Code/Part # 4500-03, UDI/DI 00732094004182; Product Code/Part # 45-15-389, UDI/DI 00732094004472; Product Code/Part # 45-22-189, UDI/DI 00732094004397; Product Code/Part # 45-23-18
00732094002423, 00732094002379, 00732094002362, 00732094113723, 00732094113693, 00732094113679, 00732094113648, 00732094113631, 00732094113600, 00732094113327, 00732094113105, 00732094112344, 00732094112290, 00732094112276, 00732094112245, 00732094112221, 00732094112207, 00732094111996, 00732094111897, 00732094111873, 00732094111842, 00732094111811, 00732094111798, 00732094111644, 00732094004199, 00732094004182, 00732094004472, 00732094004397, 00732094004380, 00732094111613, 00732094108583, 00732094108569, 00732094208610, 00732094110494, 00732094109955
Official record: FDA (Device enforcement) ↗
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