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U.S. Department of Health and Human Services

Class 2 Device Recall ProBP 3400 Digital Blood Pressure Device

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  Class 2 Device Recall ProBP 3400 Digital Blood Pressure Device see related information
Date Initiated by Firm April 22, 2021
Create Date May 21, 2021
Recall Status1 Open3, Classified
Recall Number Z-1673-2021
Recall Event ID 87749
510(K)Number K101680  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
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).
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Welch Allyn Inc
4341 State Street Rd
Skaneateles Falls NY 13153-5300
For Additional Information Contact Howard Karesh
315-685-4100
Manufacturer Reason
for Recall		 Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
FDA Determined
Cause 2		 Device Design
Action Welch Allyn, Inc. (a Hill-Rom Company) issued Customer Medical Device Correction letter ( FSCA-identifier: MOD1329) mailed (with signature service) on April 22, 2021(with signature service) via third Party. The letter states reason for recall, health risk and risk mitigations until the updated Instructions for Use (IFU) becomes available. To minimize risk of potential electrical shock be sure to follow these cleaning recommendations: When Cleaning is performed: 1. Unplug the power supply from the outlet. 2. Ensure the cleaning cloth is not soaking (not dripping or over saturated) with cleaning fluid. 3. Apply minimal pressure on wipe when cleaning; avoid wiping gap areas identified on adapter plug as these areas are most susceptible to liquid ingress. 4. Ensure the power supply and power cord are dry before plugging into electrical outlet. 5. Hold the sides of the power supply when plugging into electrical outlet as pictured below. Avoid contact with bottom of the power supply where cleaning fluid is mostly likely to have accumulated The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. Distributors will be asked to forward to their end users. They can request an electronic copy of the FSN and response form to share with end users until updated IFU becomes available. Distributors will be provided instruction on communication with their end users once response form is received. Consignees of new sales will receive the Field Safety Notice until the IFU is updated. This will be done by pulling updated consignee lists monthly and providing any new consignees with the customer letter. .
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = WELCH ALLYN, INC.
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