The Recall Desk
HighFDA (Devices)·Z-0423-2021·Announced 2020-11-11

3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where corrosion could cause performance failures, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

3M Company - Health Care Business is recalling 3M Red Dot Monitoring Electrodes with Foam Tape. The recall is due to a potential for corrosion, which could cause performance failures in the product. These electrodes are intended to be used by healthcare professionals for ECG monitoring.

The affected product is identified by Cat. No. 2228 (SKU: 70-2011-8514-0, SAP # 7100212952) and GTIN 10707387789524 (pouch) or 50707387789522 (shipper). The specific lot number is 202204MA, with an expiration date of 2020-04-27. The total quantity involved is 720,000 units.

The product was distributed worldwide, including the United States, various European countries, and other international locations. Healthcare professionals and facilities should stop using the affected electrodes and contact 3M for further instructions.

The recalled 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
3M Company - Health Care Business
Category
Medical Device — ECG Monitoring Electrodes
Hazard
Affected units
720,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Cat. No. 2228 (SKU: 70-2011-8514-0

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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