Kendall 31043170Recalls & reported problems
Cardinal Health 200, LLC · Kendall 7605 Monitoring Cloth electrode Squrae shape · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20192253017226), received between Jan 28, 2025 and Jan 28, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blister1
- Discomfort1
- Hypersensitivity/Allergic reaction1
- Itching Sensation1
- Pain1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED AN ADVERSE REACTION AFTER USING THE KENDALL 7605 CLOTH ELECTRODES WITH CONDUCTIVE ADHESIVE HYDROGEL, REF 31043170. ON DECEMBER 4, 2024, THEY USED THESE ELECTRODES AS PART OF A HOLTER MONITOR TEST THAT WAS INTENDED TO LAST FOR 14 DAYS. UNFORTUNATELY, THE PATIENT HAD TO REMOVE THE ELECTRODES AFTER JUST 4 DAYS DUE TO A SEVERE ALLERGIC REACTION. THE REACTION CAUSED SIGNIFICANT BLISTERING, SCABBING, PAIN, ITCHING, AND GENERAL DISCOMFORT. SINCE REMOVING THE ELECTRODES, THEY HAVE CONTINUED TO EXPERIENCE REDNESS, BUMPS, ITCHING, AND IRRITATION, ALONG WITH SCARRING IN THE AFFECTED AREAS. THEIR SKIN REMAINS SORE AND TENDER, AND THE IRRITATION HAS NOT FULLY SUBSIDED. PHOTOS ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 09 JAN 2025 STATED THAT THE CUSTOMER CONSULTED WITH HER PHARMACIST REGARDING THE SKIN IRRITATION. AFTER ASSESSING THE CONDITION, THE PHARMACIST RECOMMENDED THE USE OF POLYSPORIN TRIPLE ANTIBIOTIC OINTMENT DUE TO THE PRESENCE OF OPEN SORES AND THE RISK OF INFECTION, AS THE AREA APPEARED INFLAMED AND WAS PAINFUL. ADDITIONALLY, THE PHARMACIST ADVISED A TRIAL OF LOCAL CORTICOSTEROIDS AFTER A FEW DAYS TO HELP MANAGE INFLAMMATION. SHE WAS ALSO PRESCRIBED ANTIHIST
Patient problems: Blister; Discomfort; Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Skin Inflammation/ Irritation
MAUDE report 21256911 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.