medical Class II Updated 2021-11-10

3M Company - Health Care Business recalls 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with

Recalled 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 Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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.
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