Recall Z-2383-2010 ยท DRX Electrode, Electrocardiograph
3M Company / Medical Division
3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.
| Date | Sep 7, 2010 (initiated Jul 27, 2010) |
| Status | Terminated |
| Reason | The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response. |
| Root cause | Process control |
| Action | 3M sent an "Urgent Medical Device Recall" letters and a "Distributor Product Recall Form" dated July 29, 2010 to customers and distributors of the 3M and Novaplus electrodes. The letters described the 3M Red Dot and Novaplus Universal products, problems and actions to be taken by customers. Customers were instructed to examine their inventory and quarantine the affected lots pending return to the firm. After completing and returning the enclosed Customer Product Recall Form to 3M, customers will be issued a Return Authorization Number and provided with instructions for return of the affected d |
| Quantity | 11,063 cases (20 pouches/case, 50 electrodes/pouch) |
| Distribution | Nationwide Distribution: States of CA, FL, IL, KS, KY, MI, MO, NE, NJ, NY, OH, PA, RI, SD, TN, VA, and WI. |
| 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 |