Recall Z-1305-2024 ยท GYB Media, Electroconductive
Natus Neurology Inc
TENSIVE Conductive Adhesive Gel, REF 016-401600
| Date | Mar 19, 2024 (initiated Feb 7, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 | 80 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION Parker Laboratories, Inc., Aug 9, 1985 |