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 Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.

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

Code information: 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 # 45-23-189, UDI/DI 00732094004380; Product Code/Part # 5082-78, UDI/DI 00732094111613; Product Code/Part # 5200-01, UDI/DI 00732094108583; Product Code/Part # 5200-02, UDI/DI 00732094108569; 2) Product Code/Part Number 410519, UDI/DI 00732094208610; Product Code/Part Number 5090-41, UDI/DI 00732094110494; Lot Number 24-314 & lower Product Code/Part Number 5098-20, UDI/DI 00732094109955;

Distribution pattern: Worldwide distribution.