Baxter Healthcare Corporation: Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B;

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: 8233 units Lot/code info: 1) Product Code/Part # 84MTVE2-4, UDI/DI 00732094350548; 2) Product Code/Part # 84MTVE2-6, UDI/DI 00732094350463; 3) Product Code/Part # 84MTVE2-B, UDI/DI 00732094349856; 4) Product Code/Part # 84MTVE2-US, UDI/DI 00732094350388; 5) Product Code/Part # 84MTVEC-6, UDI/DI 00732094058741; 6) Product Code/Part # 84MTVEC-B, UDI/DI 00732094058734; 7) Product Code/Part # 84MTVEP-B, UDI/DI 00732094119442; 8) Product Code/Part # 84MTVEX-4, UDI/DI 00732094198638; 9) Product Code/Part # 84MTVX2-4, UDI/DI 00732094350531; 10) Product Code/Part # 84MTVX2-6, UDI/DI 00732094350456; 11) Product Code/Part # 84MTVX2-B, UDI/DI 00732094349849; 12) Product Code/Part # 84MTVX2-US, UDI/DI 00732094350371; 13) Product Code/Part # 84MTVXC-4, UDI/DI 00732094058550; 14) Product Code/Part # 84MTVXC-B, UDI/DI 00732094058512; 15) Product Code/Part # 84MTVXP-2, UDI/DI 00732094198607; 16) Product Code/Part # 84MTVXP-4, UDI/DI 00732094058390; 17) Product Code/Part # 84MTVXP-B, UDI/DI 00732094058352; 18) Product Code/Part # 84MTVXX-2, UDI/DI 00732094198584; 19) Product Code/Part # 84MXVEC-4, UDI/DI 00732094198553; 20) Product Code/Part # 84MXVEC-B, UDI/DI 00732094058277; 21) Product Code/Part # 84MXVEP-4, UDI/DI 00732094058260; 22) Product Code/Part # 84MXVEP-B, UDI/DI 00732094058222; 23) Product Code/Part # 84NTVE2-6, UDI/DI 00732094350449; 24) Product Code/Part # 84NTVE2-B, UDI/DI 00732094349832; 25) Product Code/Part # 84NTVE2-US, UDI/DI 00732094350364; 26) Product Code/Part # 84NTVEC-B, UDI/DI 00732094058048

UPC codes

00732094350548, 00732094350463, 00732094349856, 00732094350388, 00732094058741, 00732094058734, 00732094119442, 00732094198638, 00732094350531, 00732094350456, 00732094349849, 00732094350371, 00732094058550, 00732094058512, 00732094198607, 00732094058390, 00732094058352, 00732094198584, 00732094198553, 00732094058277, 00732094058260, 00732094058222, 00732094350449, 00732094349832, 00732094350364, 00732094058048, 00732094350432, 00732094349825, 00732094350357, 00732094198362, 00732094057775, 00732094057713, 00732094057652, 00732094057638, 00732094057485, 00732094198096, 00732094057065, 00732094350586, 00732094350500, 00732094349818

Source

Official record: FDA (Device enforcement) ↗

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