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Open, Classified

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

FDA Recall Z-1509-2024 · Posted 2024-04-10

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeDXN
Date Initiated2024-03-26
Product Quantity11154 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Global, US: NY, IL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101680WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIESWelch Allyn, Inc. · 2010-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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