FDA Recalls 3M Red Dot ECG Monitoring Electrodes Due to Potential Carbon Stud Breakage
3M Red Dot ECG monitoring electrodes (Catalog No. 2244) are being recalled due to potential breakage of the carbon stud from the eyelet. Approximately 2,081,000 units distributed nationwide and internationally are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall for a medical device used in critical ECG monitoring. The potential for electrode carbon stud breakage could compromise monitoring capability, but no illnesses, injuries, or fatalities have been reported, making this a theoretical risk-of-harm scenario.
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…
- Manufacturer
- 3M Company - Health Care Business
- Affected units
- 2,081,000
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 (13)
- Lot #202302LK
- Exp. 2023-02-19
- pouch UDI (01)1070738789449(17)230219(11)202302LK
- shipper box UDI (01)50707387789447(17)230219(11)202302LK Lot #202302LL
- Exp. 2023-02-22
- pouch UDI (01)1070738789449(17)230222(11)202302LL
- shipper box UDI (01)50707387789447(17)230222(11)202302LL
- Lot #202302LM
- pouch UDI (01)1070738789449(17)230222(11)202302LM
- shipper box UDI (01)50707387789447(17)230222(11)202302LM
- Lot #202302LN
- Exp. 2023-02-23. pouch UDI (01)1070738789449(17)230223(11)202302LN
- shipper box UDI (01)50707387789447(17)230223(11)202302LN.
Distribution
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