natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Recall
- Recall Number
- Z-1306-2024
- Event Number
- 93969
- Firm
- Natus Neurology Inc
- FEI Number
- 3010611950
- Product Code
- GYB
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- February 7, 2024
- Posted
- March 19, 2024
- Address
- 3150 Pleasant View Rd, Middleton, WI, 53562-4800
Description
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
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.
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.
Worldwide distribution - US Nationwide and the country of Canada.
35 units