Recall Z-0188-2022 ยท DRX Electrode, Electrocardiograph
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 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.
| Date | Oct 6, 2021 |
| Status | Terminated |
| Reason | Potential for breakage of the ECG electrode carbon stud from the eyelet. |
| Root cause | Process control |
| Action | The recalling firm, 3M Company, issued "Urgent - Medical Device Recall" letters dated 29 September 2021 to the distributors on 10/6/2021. The letter informs them of the issue and instructs them to immediately discontinue distribution of the affected lots and determine if any are in inventory. The affected product is to be destroyed by the distributor. The distributor is to notify any customers who have purchased the affected lots by using the enclosed Customer Letter and Customer Acknowledgment Form provided. The enclosed customer letter to be sent to the distributor's customers is dated |
| Quantity | 2,081,000 electrodes |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.