FDAClass IIJune 2, 2021

ProBP 3400 Digital Blood Pressure Device recall

ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures…

Why was ProBP 3400 Digital Blood Pressure Device recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All serial numbers

Product
ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures…
Recalling firm
Welch Allyn Inc
Quantity
119770 units
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 Mariana Islands (the) Norway Oman Pakistan Panama Paraguay Peru Philippines (the) Poland Portugal Puerto Rico Qatar R¿union Romania Russian Federation (the) Saudi Arabia Senegal Serbia Singapore Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan (Province of China) Thailand Trinidad and Tobago Tunisia Turkey Uganda Ukraine United Arab Emirates (the) United Kingdom Venezuela (Bolivarian Republic of) Viet Nam
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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