• 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 NOVAPLUS see related information
Date Initiated by Firm September 30, 2004
Date Posted October 22, 2004
Recall Status1 Terminated 3 on November 14, 2005
Recall Number Z-0037-05
Recall Event ID 30137
510(K)Number K833364  
Product Classification Electrode, Electrosurgical - Product Code JOS
Product NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Code Information Lot 2007-06 HP
Recalling Firm/
3M Company / Medical Division
3M Center, Bldg 275-05-W-06
South St Paul MN 55411
For Additional Information Contact Suzanne M. Danielson
Manufacturer Reason
for Recall
Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.
FDA Determined
Cause 2
Action A recall notification letter dated 09/30/2004 was sent to Hospitals and Health Care Distributors instructing consignees to immedately remove all effective product from lot 2007-06 HP.
Quantity in Commerce 384 cases containing 40 pads each for a total of 15,360 pads
Distribution The subject product lot was distributed to the following key 3M distributors: Owens & Minor, Cardinal Health, McKesson, Professional Health Supply, and the Burrows Company.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JOS and Original Applicant = 3M COMPANY