3M Company - Health Care Business: 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 p

Is my product affected?

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 Radiolucent Monitoring E

• UPC 1070738789449
• UPC 50707387789447

Check against the official notice below — it lists the full affected range.

What happened

3M Company is recalling 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape (Catalog No. 2244) because the carbon stud of the ECG electrode may break away from the eyelet. The product was distributed nationwide to eleven U.S. states (Alabama, Arizona, California, Iowa, Illinois, Louisiana, Maryland, Missouri, North Carolina, New Jersey, and Ohio) and internationally to eleven countries (Australia, Bermuda, Canada, China, France, Germany, Japan, the Netherlands, Singapore, Sweden, and Turkey). A total of 2,081,000 electrodes are affected, spanning four lot numbers with expiration dates ranging from February 19-23, 2023.

The recall notice does not specify a remedy or what affected consumers should do with the product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for breakage of the ECG electrode carbon stud from the eyelet.

Details from the source

Reason for recall: Potential for breakage of the ECG electrode carbon stud from the eyelet. Distribution: US Nationwide Distribution to states of: AL, AZ, CA, IA, IL, LA, MD, MO, NC, NJ, and OH; and OUS Foreign distribution to countries of: Australia, Bermuda, Canada, China, France, Germany, Japan, the Netherlands, Singapore, Sweden, and Turkey. Quantity: 2,081,000 electrodes Lot/code info: 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, Exp. 2023-02-22, 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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