Recall Z-0419-2021
3M Company - Health Care Business · initiated September 15, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: 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)
Reason for recall
Corrosion could cause performance failures in the product.
FDA-determined cause: Process control
Action taken
The recalling firm issued customer letters to consignees on 10/7-8/2020. The recalling firm is requesting a returned acknowledgement form from the consignee. Distributors will also be sent a template customer letter and customer acknowledgement so that they may notify their customers. The recalling firm will initiate multiple attempts to follow up with non responders. Customers and distributors are requested to dispose of any products still in their possession.
Details
- Recall number
- Z-0419-2021
- Initiated
- September 15, 2020
- Terminated
- February 1, 2022
- Product code
- DRX – Electrode, Electrocardiograph
- Quantity
- 1,572,000 units
- 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).
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0420-2021 Class II | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended…Corrosion could cause performance failures in the product. | 09/15/2020Terminated |
| Z-0421-2021 Class II | 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by…Corrosion could cause performance failures in the product. | 09/15/2020Terminated |
| Z-0422-2021 Class II | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by…Corrosion could cause performance failures in the product. | 09/15/2020Terminated |
| Z-0423-2021 Class II | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by…Corrosion could cause performance failures in the product. | 09/15/2020Terminated |