FDA Recalls 3M Red Dot ECG Monitoring Electrodes Due to Potential Carbon Stud Breakage

Plain-English summary

3M Red Dot Radiolucent Monitoring Electrodes with Foam Tape (Catalog No. 2244) are being recalled by 3M Company - Health Care Business. These electrodes are disposable medical devices intended for single-use ECG monitoring by healthcare professionals and are rated for up to 3 days of wear.

The recall is being issued due to the potential for breakage of the ECG electrode carbon stud from the eyelet. This breakage could compromise the electrode's function during patient monitoring.

The recall affects 2,081,000 electrodes from four affected lot numbers (202302LK, 202302LL, 202302LM, and 202302LN) with expiration dates ranging from February 19 to February 23, 2023. These electrodes were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Iowa, Illinois, Louisiana, Maryland, Missouri, North Carolina, New Jersey, and Ohio, as well as internationally to Australia, Bermuda, Canada, China, France, Germany, Japan, the Netherlands, Singapore, Sweden, and Turkey.

Healthcare providers who have received or are using these electrodes should discontinue use and contact 3M Company for replacement or removal instructions.

The recalled product

Product

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot R

Manufacturer

3M Company - Health Care Business

Category

Medical Device — ECG Monitoring Electrode

Hazard

• electrode-breakage
• device-malfunction

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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