FDAClass IINovember 11, 2020

3M Red Dot Monitoring Electrode with Foam Tape recall

3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per…

Why was 3M Red Dot Monitoring Electrode with Foam Tape recalled?

Corrosion could cause performance failures in the product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Cat. No. 2228 (SKU: 70-2011-8514-0, SAP # 7100212952). GTIN: 10707387789524 (pouch) and 50707387789522 (shipper) Lots: 202204MA (Expiration 2020-04-27)

Product
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per…
Recalling firm
3M Company - Health Care Business
Quantity
720,000
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).
Recall date
November 11, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls