Hillrom Welch Allyn Connex ProBP 3400 Digital Blood… recallZ-1509-2024 · Baxter Healthcare Corporation · initiated Mar 26, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Baxter issued an Urgent Medical Device Correction notice to its consignees on 03/26/2024 via USPS, first class mail. The notice explained the issue, hazard, and provided the following: Actions to be taken by customers: 1. Healthcare providers may continue to use the non-compliant power cords, but if any fraying or damage is observed, users should NOT make physical contact with the cord and discard the power cord immediately. 2. Healthcare providers should regularly inspect the power cords for fraying or other damage. 3. Once Baxter has replacement power cords, a follow-up notification will be sent with additional instructions on how to request replacement power cords. 4. Customers will be asked to acknowledge receipt of the Urgent Medical Device Correction notification by responding on our customer portal. 5. If the product has been distributed to other facilities or departments within the institution, customers will be asked to forward a copy of the Urgent Medical Device Correction notification to them. 6. If the customer is a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, they will be asked to notify their customers of this Urgent Medical Device Correction according to their customary procedures and check the associated box on the customer portal.

Recall details

Recall number: Z-1509-2024
Status: Open, Classified
Initiated by the company: Mar 26, 2024
Posted by the FDA: Apr 10, 2024
Recalling firm: Baxter Healthcare Corporation
Quantity: 11154 units
Product code: DXN
FDA submissions: K101680
Distribution: Global, US: NY, IL

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

1 device cleared under K101680 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Welch Allyn, Inc. 901057
Welch Allyn, Inc. · Oximeter
1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 94295).

Z-1510-2024 · Open, Classified
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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