Z-0419-2021 Class II Terminated
FDA device recall Z-0419-2021 was initiated by 3M Company - Health Care Business on September 15, 2020 and is designated Class II. Reason for recall: Corrosion could cause performance failures in the product. The recall status is terminated (terminated February 1, 2022). Affected quantity: 1,572,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- September 15, 2020
- Termination Date
- February 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,572,000 units
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.
Distribution Pattern
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).
Code Information
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)