Recall Z-0188-2022— 3M Company - Health Care Business
Class II · Terminated
Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2021-10-06, terminated 2024-01-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for breakage of the ECG electrode carbon stud from the eyelet..
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-06
- Terminated
- 2024-01-17
- Firm location
- Saint Paul, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.