Device product
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Z-1204-2024
Product summary
- Event
- Event 93891
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44 cases (6,336 units) (39 cases US, 5 cases OUS)
- Official record key
device-enforcement:Z-1204-2024
Official wording
Reason: Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
Code information: Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
Distribution pattern: US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
Derived failure modes
-
Unknown
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.