3M Red Dot 2560 & 2570 Monitoring Electrodes

• 5 recalls, same reason

  • Terminated Z-0419-2021 FDA Class II ·initiated 15 Sep 2020
  • Terminated Z-0422-2021 FDA Class II ·initiated 15 Sep 2020
  • Terminated Z-0421-2021 FDA Class II ·initiated 15 Sep 2020
  • Terminated Z-0420-2021 FDA Class II ·initiated 15 Sep 2020
  • Terminated Z-0423-2021 FDA Class II ·initiated 15 Sep 2020

  Corrosion could cause performance failures in the product.

• • Terminated Z-2383-2010 FDA Unclassified (pre-2012) ·initiated 27 Jul 2010

  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.

510(k) Number

K970796 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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