Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

TENSIVE Conductive Adhesive Gel, REF 016-401600

FDA Recall Z-1305-2024 · Posted 2024-03-19

Recalling FirmNatus Neurology Inc
Recall StatusOpen, Classified
Product CodeGYB
Date Initiated2024-02-07
Product Quantity80 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K852956CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITIONParker Laboratories, Inc. · 1985-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑