Z-1509-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2024
- Initiation Date
- March 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11154 units
Product Description
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,AU, Product Code 34BFST-6; d) PROBP 3400, BLUETOOTH, MOBILE, EU, Product Code 34BXST-2; e) PROBP 3400, BLUETOOTH, MOBILE, UK, Product Code 34BXST-4; f) PROBP 3400, BLUETOOTH, MOBILE, ZA, Product Code 34BXST-7; g) PROBP 3400, SUREBP, MOBILE, EU, Product Code 34XFST-2; h) PROBP 3400, SUREBP, MOBILE, UK, Product Code 34XFST-4; i) PROBP 3400, SUREBP, MOBILE, AU, Product Code 34XFST-6; j) PROBP 3400, SUREBP, MOBILE, ZA, Product Code 34XFST-7; k) PROBP 3400, MOBILE, EU, Product Code 34XXST-2; l) PROBP 3400, MOBILE, UK, Product Code 34XXST-4; m) PROBP 3400, MOBILE, AU, Product Code 34XXST-6; n) PROBP 3400, MOBILE, ZA, Product Code 34XXST-7; o) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-5WT-2; p) PROBP MOBILE STAND CORD ASSY UK, Product Code PWCD-5WT-4; q) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-5WT-6; r) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-5WT-7; s) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-6WT-2; t) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-6WT-6; u) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-6WT-7
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 Pattern
Global, US: NY, IL
Code Information
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