Device product
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).
Z-0423-2021
Product summary
- Event
- Event 86519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720,000
- Official record key
device-enforcement:Z-0423-2021
Official wording
Reason: Corrosion could cause performance failures in the product.
Code information: Cat. No. 2228 (SKU: 70-2011-8514-0, SAP # 7100212952). GTIN: 10707387789524 (pouch) and 50707387789522 (shipper) Lots: 202204MA (Expiration 2020-04-27)
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.