• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Novaplus

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Novaplussee related information
Date Initiated by FirmSeptember 15, 2020
Create DateNovember 05, 2020
Recall Status1 Terminated 3 on February 01, 2022
Recall NumberZ-0420-2021
Recall Event ID 86519
510(K)NumberK970796 
Product Classification Electrode, electrocardiograph - Product Code DRX
ProductNovaplus 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).
Code Information Cat. No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820). GTIN: 10707387788169 (pouch); 50707387788167 (shipper)  Lots: 202201EB (Expiration 2022-01-01)
Recalling Firm/
Manufacturer
3M Company - Health Care Business
3m Center 2510 Conway Ave
Bldg 275-5W-06
Saint Paul MN 55144-0001
For Additional Information ContactNaomi Rodiles
651-733-1110
Manufacturer Reason
for Recall
Corrosion could cause performance failures in the product.
FDA Determined
Cause 2
Process control
ActionThe 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.
Quantity in Commerce156,600 units
DistributionWorldwide 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).
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DRX
-
-