Device product
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).
Z-0419-2021
Product summary
- Event
- Event 86519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,572,000 units
- Official record key
device-enforcement:Z-0419-2021
Official wording
Reason: Corrosion could cause performance failures in the product.
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)
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).
Derived failure modes
-
Unknown
Corrosion could cause performance failures in the product.