3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
Check against the official notice below — it lists the full affected range.
3M Company is recalling 3M Red Dot Monitoring Electrodes with 4mm Adapter (Cat. No. 2228BA) used by healthcare professionals for ECG monitoring. The recall affects 287,200 units distributed worldwide, including throughout the United States, multiple European countries (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, and Sweden), and other regions including China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, and Canada. The affected products are identified by SKU CH-0000-1642-8 and include 14 specific lot numbers with expiration dates ranging from April 20, 2020 to June 2, 2020.
The recall was initiated because corrosion could cause performance failures in the product. The source document does not specify a remedy or instructions for affected consumers.
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: 287,200 units Lot/code info: Cat. No. 2228BA (SKU: CH-0000-1642-8, SAP #: 7000032072). GTIN: 10707387582200 (pouch); 50707387786996 (shipper) Lots: 202204BA (Expiration 2020-04-20); 202204BB (Expiration 2020-04-22); 202204BC (Expiration 2020-04-27); 202204BD (Expiration 2020-04-28); 202204BE (Expiration 2020-04-29); 202204BF (Expiration 2020-04-30); 202204BG (Expiration 2020-05-04); 202204BH (Expiration 2020-05-05); 202204BI (Expiration 2020-05-07); 202204BJ (Expiration 2020-05-12); 202204BK (Expiration 2020-05-14); 202204BL (Expiration 2020-05-22); 202204BM (Expiration 2020-05-28); and 202204BN (Expiration 2020-06-02)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.