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FDA (Device enforcement)Recalled 2025-03-21class ii

Baxter Healthcare Corporation: Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reu

Hazard

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Details from the source

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

UPC codes

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

Source

Official record: FDA (Device enforcement)

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

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