Recall Z-0419-2021— 3M Company - Health Care Business

Name: FDA recall Z-0419-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-15

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2020-09-15, terminated 2022-02-01. It names one FDA 510(k) clearance: K970796. Product: Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).. Reason: Corrosion could cause performance failures in the product..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2020-09-15
Terminated: 2022-02-01
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K970796 — 3M RED DOT 2560 & 2570 MONITORING ELECTRODES3M Healthcare·cleared 1997-04-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).

Reason for recall

Corrosion could cause performance failures in the product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.