medical Class II Updated 2025-04-23

Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor, Product Code/Part Nu

Recalled Product

Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/Part # 67NCTP-B-ECG3A; 7) ) Product Code/Part # 67NCTX-B; 8) ) Product Code/Part # 67NXEX-B; 9) ) Product Code/Part # 67NXTP-B; 10) ) Product Code/Part # 67NXTP-B-ECG3A; 11) ) Product Code/Part # 67NXTX-B; 12) ) Product Code/Part # 67NXXX-B; 13) ) Product Code/Part # 68MCTP-B; 14) ) Product Code/Part # 68MCTP-B-ECG3A; 15) ) Product Code/Part # 68MCTX-B; 16) ) Product Code/Part # 68MCXX-B; 17) ) Product Code/Part # 68MXDX-B; 18) ) Product Code/Part # 68MXEP-B; 19) ) Product Code/Part # 68MXEX-B; 20) ) Product Code/Part # 68MXTP-B; 21) ) Product Code/Part # 68MXTP-B-ECG3A; 22) ) Product Code/Part # 68MXTX-B; 23) ) Product Code/Part # 68MXTX-BR; 24) ) Product Code/Part # 68NCEP-B; 25) ) Product Code/Part # 68NCTP-B; 26) ) Product Code/Part # 68NCTP-B-ECG3A; 27) ) Product Code/Part # 68NCTX-B; 28) ) Product Code/Part # 68NCXP-B; 29) ) Product Code/Part # 68NXEP-B; 30) ) Product Code/Part # 68NXEX-B; 31) ) Product Code/Part # 68NXTP-B; 32) ) Product Code/Part # 68NXTP-B-ECG3A; 33) ) Product Code/Part # 68NXTX-B; 34) ) Product Code/Part # 68NXTX-BR; 35) ) Product Code/Part # 68NXXX-B; 36) ) Product Code/Part # 67MCTP-B; 37) ) Product Code/Part # 67MCTP-B-ECG3A; 38) ) Product Code/Part # 67MCTX-B; 39) ) Product Code/Part # 67MXEX-B; 40) ) Product Code/Part # 67MXTP-B; 41) ) Product Code/Part # 68MXXX-B.

Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: 1) Product Code/Part # 67MXTP-B-ECG3A, UDI/DI 00732094323788; 2) Product Code/Part # 67MXTX-B, UDI/DI 00732094151244; 3) Product Code/Part # 67MXXP-B, UDI/DI 00732094151237; 4) Product Code/Part # 67MXXX-B, UDI/DI 00732094151220; 5) Product Code/Part # 67NCTP-B, UDI/DI 00732094151190; 6) Product Code/Part # 67NCTP-B-ECG3A, UDI/DI 00732094323771; 7) Product Code/Part # 67NCTX-B, UDI/DI 00732094151183; 8) Product Code/Part # 67NXEX-B, UDI/DI 00732094151145; 9) Product Code/Part # 67NXTP-B, UDI/DI 00732094151138; 10) Product Code/Part # 67NXTP-B-ECG3A, UDI/DI 00732094323764; 11) Product Code/Part # 67NXTX-B, UDI/DI 00732094151121; 12) Product Code/Part # 67NXXX-B, UDI/DI 00732094151107; 13) Product Code/Part # 68MCTP-B, UDI/DI 00732094151060; 14) Product Code/Part # 68MCTP-B-ECG3A, UDI/DI 00732094345919; 15) Product Code/Part # 68MCTX-B, UDI/DI 00732094151053; 16) Product Code/Part # 68MCXX-B, UDI/DI 00732094151039; 17) Product Code/Part # 68MXDX-B, UDI/DI 00732094249187; 18) Product Code/Part # 68MXEP-B, UDI/DI 00732094150964; 19) Product Code/Part # 68MXEX-B, UDI/DI 00732094150957; 20) Product Code/Part # 68MXTP-B, UDI/DI 00732094150940; 21) Product Code/Part # 68MXTP-B-ECG3A, UDI/DI 00732094345902; 22) Product Code/Part # 68MXTX-B, UDI/DI 00732094150933; 23) Product Code/Part # 68MXTX-BR, UDI/DI 00732094322613; 24) Product Code/Part # 68NCEP-B, UDI/DI 00732094150902; 25) Product Code/Part # 68NCTP-B, UDI/DI 00732094150889; 26) Product Code/Part # 68NCTP-B-ECG3A, UDI/DI 00732094345896; 27) Product Code/Part # 68NCTX-B, UDI/DI 00732094150872; 28) Product Code/Part # 68NCXP-B, UDI/DI 00732094150865; 29) Product Code/Part # 68NXEP-B, UDI/DI 00732094150841; 30) Product Code/Part # 68NXEX-B, UDI/DI 00732094150834; 31) Product Code/Part # 68NXTP-B, UDI/DI 00732094150827; 32) Product Code/Part # 68NXTP-B-ECG3A, UDI/DI 00732094345889; 33) Product Code/Part # 68NXTX-B, UDI/DI 00732094150810; 34) Product Code/Part # 68NXTX-BR, UDI/DI 00732094322590; 35) Product Code/Part # 68NXXX-B, UDI/DI 00732094150797; 36) Product Code/Part # 67MCTP-B, UDI/DI 00732094151374; 37) Product Code/Part # 67MCTP-B-ECG3A, UDI/DI 00732094323795; 38) Product Code/Part # 67MCTX-B, UDI/DI 00732094151367; 39) Product Code/Part # 67MXEX-B, UDI/DI 00732094151268; 40) Product Code/Part # 67MXTP-B, UDI/DI 00732094151251; 41) Product Code/Part # 68MXXX-B, UDI/DI 00732094150919; Lot Number 24-314 & lower
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