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FDA (Device enforcement)Recalled 2020-09-15closedclass ii

3M Company - Health Care Business: Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per ca

Is my product affected?

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).

  • UPC 10707387788169
  • UPC 50707387788167

Check against the official notice below — it lists the full affected range.

What happened

3M Company is recalling 156,600 units of Novaplus Monitoring Electrode with Foam Tape and Sticky Gel worldwide. The product, which is intended for use by healthcare professionals for ECG monitoring and contains three electrodes per package, is subject to recall because corrosion could cause performance failures. The affected product is identified by catalog number V2560-3 (SKU: 70-2011-8380-6) with lot number 202201EB and expiration date of January 1, 2022.

The recalled electrodes were distributed nationwide in the United States and to numerous countries in Europe and Asia, including Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Sweden, China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, and Canada. The source record does not specify what remedy or action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Corrosion could cause performance failures in the product.

Details from the source

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: 156,600 units Lot/code info: Cat. No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820). GTIN: 10707387788169 (pouch); 50707387788167 (shipper) Lots: 202201EB (Expiration 2022-01-01)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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