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).
Check against the official notice below — it lists the full affected range.
3M Company is recalling approximately 1.57 million units of Novaplus Monitoring Electrodes with Foam Tape and Sticky Gel used by healthcare professionals for ECG monitoring. The electrodes are being recalled because corrosion could cause performance failures in the product. The affected product is identified as Cat. No. V2560-5 (SKU: 70-2011-8381-4) in four specific lots: 202112EQ (expiring December 9, 2021), 202201EA (expiring January 1, 2022), 202205EH (expiring May 14, 2022), and 202205EI (expiring May 19, 2022). The affected electrodes were distributed nationwide in the United States and internationally across Europe, Asia, and the Americas.
The recall notice does not specify a remedy for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
Corrosion could cause performance failures in the product.
Reason for recall: Corrosion could cause performance failures in the product. 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). Quantity: 1,572,000 units Lot/code info: Cat. No. V2560-5 (SKU: 70-2011-8381-4, SAP #: 7100205978). GTIN: 10707387788176 (pouch) and 50707387788174 (shipper) Lots: 202112EQ (Expiration 2021-12-09); 202201EA (Expiration 2022-01-01); 202205EH (Expiration 2022-05-14); and 202205EI (Expiration 2022-05-19)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.