Recall Z-0423-2021 ยท DRX Electrode, Electrocardiograph
3M Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
| Date | Sep 15, 2020 |
| Status | Terminated |
| Reason | Corrosion could cause performance failures in the product. |
| Root cause | Process control |
| Action | The recalling firm issued customer letters to consignees on 10/7-8/2020. The recalling firm is requesting a returned acknowledgement form from the consignee. Distributors will also be sent a template customer letter and customer acknowledgement so that they may notify their customers. The recalling firm will initiate multiple attempts to follow up with non responders. Customers and distributors are requested to dispose of any products still in their possession. |
| Quantity | 720,000 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES 3M Healthcare, Apr 9, 1997 |