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).
Reported: November 11, 2020 Initiated: September 15, 2020 #Z-0422-2021
Product Description
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).
Reason for Recall
Corrosion could cause performance failures in the product.
Details
- Recalling Firm
- 3M Company - Health Care Business
- Units Affected
- 10,145,050 units
- Distribution
- 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).
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by 3M Company - Health Care Business. Units affected: 10,145,050 units.
Why was this product recalled? ▼
Corrosion could cause performance failures in the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0422-2021.
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