Z-0188-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- October 6, 2021
- Termination Date
- January 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,081,000 electrodes
Product Description
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.
Reason for Recall
Potential for breakage of the ECG electrode carbon stud from the eyelet.
Distribution Pattern
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.
Code Information
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.