FDAFDA · Food and drugs·Recall number Z-1306-2024
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Published March 27, 2024 · Recall initiated: February 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Natus Neurology Inc
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- UDI/DI x, Lot Numbers: 614922, 614923, 614921, 122923, 628166
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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