# FDA recall Z-1673-2021

> **Welch Allyn Inc** · Class II · device recall initiated 2021-04-22.

## Product

ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models)  Model:      34XFHT-B    Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).

## Reason for recall

Potential Risk of fluid ingress to the power supplies,  resulting in risk of an internal electrical short and possible electrical shock

## Distribution

Worldwide - US Nationwide distribution  Foreign:  Afghanistan  Albania  Algeria  American Samoa  Argentina  Australia  Austria  Azerbaijan  Bahamas (the)  Bahrain  Bangladesh  Barbados  Belgium  Bermuda  Bhutan  Bolivia (Plurinational State of)  Botswana  Brazil  Brunei Darussalam  Bulgaria  Cameroon  Canada  Chad  Chile  China  Colombia  Congo (the Democratic Republic of the)  Congo (the)  Costa Rica  Croatia  Cyprus  Czechia  Denmark  Dominican Republic (the)  Ecuador  Egypt  El Salvador  Estonia  Eswatini  Finland  France  French Polynesia  Georgia  Germany  Ghana  Greece  Guam  Guatemala  Honduras  Hong Kong  Hungary  Iceland  India  Indonesia  Iran (Islamic Republic of)  Iraq  Ireland  Israel  Italy  Jamaica  Japan  Jordan  Kenya  Korea (the Republic of)  Kuwait  Lao People's Democratic Republic (the)  Latvia  Lebanon  Lesotho  Libya  Luxembourg  Malaysia  Maldives  Malta  Mexico  Mozambique  Myanmar  Namibia  Nepal  Netherlands (the)  New Zealand  Nicaragua  Nigeria  Northern Mar

## Key facts

- **Recall number:** Z-1673-2021
- **Recalling firm:** Welch Allyn Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-22
- **Report date:** 2021-06-02
- **Termination date:** 2024-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Skaneateles Falls, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1673-2021

## Citation

> AI Analytics. FDA recall Z-1673-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1673-2021. Source: US FDA. Licensed CC0.

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