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).
Check against the official notice below — it lists the full affected range.
3M Company has recalled approximately 10.1 million units of 3M Red Dot Monitoring Electrodes with Foam Tape (product category number 2228) used by healthcare professionals for ECG monitoring. The electrodes come in pouches containing 50 units. The recall affects specific lot numbers produced in April 2022 with expiration dates ranging from April 7 to April 24, 2020, and these products were distributed worldwide, including throughout the United States, multiple European countries, and Asia-Pacific regions. The reason for the recall is that corrosion could cause performance failures in the product.
The recall notice does not specify a remedy or corrective action for consumers who have obtained these electrodes.
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: 10,145,050 units Lot/code info: Cat. No. 2228 (SKU: 70-2007-8021-4, SAP # 7100009333). GTIN: 10707387582200 (pouch) and 50707387786996 (shipper) Lots:202204LF (Expiration 2020-04-07); 202204LG (Expiration 2020-04-08); 202204LH (Expiration 2020-04-09); 202204LJ (Expiration 2020-04-13); 202204LK (Expiration 2020-04-13); 202204LL (Expiration 2020-04-14); 202204LM (Expiration 2020-04-15); 202204LN (Expiration 2020-04-16); 202204LP (Expiration 2020-04-17); 202204LQ (Expiration 2020-04-17); 202204LR (Expiration 2020-04-20); 202204LS (Expiration 2020-04-20); 202204LT (Expiration 2020-04-21); 202204LU (Expiration 2020-04-21); 202204LV (Expiration 2020-04-22); 202204LW (Expiration 2020-04-22); and 202204LY (Expiration 2020-04-24)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.