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U.S. Department of Health and Human Services

Class 2 Device Recall Natus neurology TENSIVE

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 Class 2 Device Recall Natus neurology TENSIVEsee related information
Date Initiated by FirmFebruary 07, 2024
Date PostedMarch 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1305-2024
Recall Event ID 93969
510(K)NumberK852956 
Product Classification Media, electroconductive - Product Code GYB
ProductTENSIVE 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
ActionNatus 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 Commerce80 units
DistributionWorldwide distribution - US Nationwide and the country of 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 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) Database510(K)s with Product Code = GYB
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