There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Reason for recall: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter. Distribution: Worldwide - US Nationwide distribution. Quantity: 228,412 units Lot/code info: All Serial Numbers. Product Code: 67MCTX-4, UDI-DI: 00732094193787; Product Code: 67MCTX-6, UDI-DI: 00732094194654; Product Code: 67MCTX-B, UDI-DI: 00732094151367; Product Code: 67MCXP-B, UDI-DI: 00732094151350; Product Code: 67MCXX-B, UDI-DI: 00732094151343; Product Code: 67MREP-B, UDI-DI: 00732094151336; Product Code: 67MREX-B, UDI-DI: 00732094151329; Product Code: 67MRTP-B, UDI-DI: 00732094151312; Product Code: 67MRTX-B, UDI-DI: 00732094151305; Product Code: 67MRXP-4, UDI-DI: 00732094193640; Product Code: 67MRXP-B, UDI-DI: 00732094151299; Product Code: 67MRXX-B, UDI-DI: 00732094151282; Product Code: 67MSTP-6, UDI-DI: 00732094194548; Product Code: 67MSTP-B, UDI-DI: 00732094177541; Product Code: 67MSTX-6, UDI-DI: 00732094194531; Product Code: 67MSTX-B, UDI-DI: 00732094177558; Product Code: 67MXDX-B, UDI-DI: 00732094249163; Product Code: 67MXEP-2, UDI-DI: 00732094193619; Product Code: 67MXEP-4, UDI-DI: 00732094193602; Product Code: 67NCEP-2, UDI-DI: 00732094193497; Product Code: 67NCEP-6, UDI-DI: 00732094194449; Product Code: 67NCEP-B, UDI-DI: 00732094151213; Product Code: 67NCEX-4, UDI-DI: 00732094193466; Product Code: 67NCTP-B, UDI-DI: 00732094151190; Product Code: 67NCTP-B-ECG3A, UDI-DI: 00732094323771; Product Code: 67NCTX-B, UDI-DI: 00732094151183; Product Code: 67NCXP-2, UDI-DI: 00732094193411; Product Code: 67NCXP-6, UDI-DI: 00732094194401; Product Code: 67NCXP-B, UDI-DI: 00732094151176; Product Code: 67NCXX-4, UDI-DI: 00732094193381; Product Code: 67NCXX-6, UDI-DI: 00
00732094193787, 00732094194654, 00732094151367, 00732094151350, 00732094151343, 00732094151336, 00732094151329, 00732094151312, 00732094151305, 00732094193640, 00732094151299, 00732094151282, 00732094194548, 00732094177541, 00732094194531, 00732094177558, 00732094249163, 00732094193619, 00732094193602, 00732094193497, 00732094194449, 00732094151213, 00732094193466, 00732094151190, 00732094323771, 00732094151183, 00732094193411, 00732094194401, 00732094151176, 00732094193381, 00732094194395, 00732094151169, 00732094189339, 00732094194364, 00732094206678, 00732094177503, 00732094177534, 00732094249149, 00732094193374, 00732094193367
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.