Home / Recalls / Medical Devices
3M Company - Health Care Business recalls 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG
Recalled November 11, 2020 · FDA recall Z-0422-2021 · 3M Company - Health Care Business
Hazard
Corrosion could cause performance failures in the product. · FDA Class II
Units
10,145,050 units
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).
Description
Corrosion could cause performance failures in the product.
Product
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
Manufacturer(s)
3M Company - Health Care Business
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →