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FDA (Device enforcement)Recalled 2024-03-26class ii

Baxter Healthcare Corporation: Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFS

Hazard

Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.

Details from the source

Reason for recall: Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards. Distribution: Global, US: NY, IL Quantity: 11154 units Lot/code info: a) 34BFST-2, UDI/DI 732094009385; b) 34BFST-4, UDI/DI 732094009378; c) 34BFST-6, UDI/DI 732094009361; d) 34BXST-2, UDI/DI 732094009248; e) 34BXST-4, UDI/DI 732094167733; f) 34BXST-7, UDI/DI 732094009231; g) 34XFST-2, UDI/DI 732094009057; h) 34XFST-4, UDI/DI 732094009040; i) 34XFST-6, UDI/DI 732094009033; j) 34XFST-7, UDI/DI 732094009026; k) 34XXST-2, UDI/DI 732094008852; l) 34XXST-4, UDI/DI 732094008845; m) 34XXST-6, UDI/DI 732094008838; n) 34XXST-7, UDI/DI 732094008821; o) PWCD-5WT-2, UDI/DI 732094072402; p) PWCD-5WT-4, UDI/DI 732094155808; q) PWCD-5WT-6, UDI/DI 732094072389; r) PWCD-5WT-7, UDI/DI 732094072365; s) PWCD-6WT-2, UDI/DI 732094347494; t) PWCD-6WT-6, UDI/DI 732094347470; u) PWCD-6WT-7, UDI/DI 732094347463

UPC codes

732094009385, 732094009378, 732094009361, 732094009248, 732094167733, 732094009231, 732094009057, 732094009040, 732094009033, 732094009026, 732094008852, 732094008845, 732094008838, 732094008821, 732094072402, 732094155808, 732094072389, 732094072365, 732094347494, 732094347470, 732094347463

Source

Official record: FDA (Device enforcement)

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

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