Z-1509-2024Class II

Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a)...

Name: Z-1509-2024 Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a)...
Creator: Baxter Healthcare Corporation
Published: 2024-03-26
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-03-26 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product... on 2024-03-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1509-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-26
Posted: 2024-04-10
Recalling firm: Baxter Healthcare Corporation
Product: 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
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 11154 units
Distribution: Global, US: NY, IL
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1509-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1509-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-10
Z-1510-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-10
Z-1511-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-10

Product code DXN

K101680Class IIWelch Allyn Spot Vital Signs Lxi Model 45000 SeriesWelch Allyn, Inc. / cleared 2010-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)