FDA-Device2020-11-11Class II
3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
3M Company - Health Care Business
Hazard
Corrosion could cause performance failures in the product.
Sold states
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).
Affected count
287,200 units
Manufactured in
3m Center 2510 Conway Ave, Bldg 275-5W-06, Saint Paul, MN, United States
Products
3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0421-2021Don't want to check this manually?
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