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: 385920 units Lot/code info: 1) Product Code/Part # 5098-02, UDI/DI 00732094110128; Product Code/Part # 5098-23, UDI/DI 00732094109900; Product Code/Part # 5098-27, UDI/DI 00732094109856; Product Code/Part # 5098-28, UDI/DI 00732094109801; Product Code/Part # 5098-29, UDI/DI 00732094109764; Product Code/Part # 5098-30, UDI/DI 00732094109726; Product Code/Part # 5098-33, UDI/DI 00732094109658; Product Code/Part # 5098-42, UDI/DI 00732094109603; Product Code/Part # DS44-09, UDI/DI 00732094085884; Product Code/Part # DS44-11, UDI/DI 00732094085631; Product Code/Part # DS44-11C, UDI/DI 00732094085617; Product Code/Part # DS44-MC, UDI/DI 00732094084924; Product Code/Part # DS45-11, UDI/DI 00732094084610; Product Code/Part # DS45-11C, UDI/DI 00732094084498; Product Code/Part # DS45-12, UDI/DI 00732094084429; Product Code/Part # DS45-MC, UDI/DI 00732094083965; Product Code/Part # DS58-11, UDI/DI 00732094083385; Product Code/Part # DS58-MC, UDI/DI 00732094083347; Product Code/Part # DS58-PD, UDI/DI 00732094083309; Product Code/Part # DS58-ST, UDI/DI 00732094083170; 2) Product Code/Part Number 407637, UDI/DI 00732094046755; 3) Product Code/Part Number 7670-10,UDI/DI 00732094071511; Lot Number 24-314 & lower
00732094110128, 00732094109900, 00732094109856, 00732094109801, 00732094109764, 00732094109726, 00732094109658, 00732094109603, 00732094085884, 00732094085631, 00732094085617, 00732094084924, 00732094084610, 00732094084498, 00732094084429, 00732094083965, 00732094083385, 00732094083347, 00732094083309, 00732094083170, 00732094046755, 00732094071511
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.