Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Natus neurology TENSIVE

  • 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 Natus neurology TENSIVE see related information
Date Initiated by Firm February 07, 2024
Date Posted March 19, 2024
Recall Status1 Open3, Classified
Recall Number Z-1305-2024
Recall Event ID 93969
510(K)Number K852956  
Product Classification Media, electroconductive - Product Code GYB
Product TENSIVE Conductive Adhesive Gel, REF 016-401600
Code Information UDI/DI 00855683006333, Lot Numbers: A0623009
Recalling Firm/
Manufacturer		 Natus Neurology Inc
3150 Pleasant View Rd
Middleton WI 53562-4800
For Additional Information Contact
608-829-8500
Manufacturer Reason
for Recall		 Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five complaints. These customers reported that the gel is too thick, is discolored (darker than usual), and in one instance, patients reported irritation after procedures using the gel.
FDA Determined
Cause 2		 Under Investigation by firm
Action Natus issued an Urgent Medical Device Recall Notice to its consignees on 02/07/2024 via UPS and email. The notice explained the issue and risk to health. It also requested the consignee cease use, complete and return the form for the replacement of the product.
Quantity in Commerce 80 units
Distribution Worldwide distribution - US Nationwide and the country of Canada.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GYB and Original Applicant = PARKER LABORATORIES, INC.
-
-