Recall Z-1204-2024 ยท GYB Media, Electroconductive
Parker Laboratories, Inc.
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
| Date | Feb 29, 2024 (initiated Jan 22, 2024) |
| Status | Open, Classified |
| Reason | Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. |
| Root cause | Under Investigation by firm |
| Action | An"URGENT MEDICAL DEVICE REVALL" NOTIFICATION letter dated January 22, 2024, was sent to Customers. It instructed customers to perform the following: Immediately examine your inventory for the affected product. Discontinue distribution and quarantine any affected product in your inventory. Should you identify any customers to whom the affected product may have already been distributed, please perform a sub-recall to your direct accounts. The notification letter and response form may be used as a basis for your sub-recall letter. Please complete the attached response form as soon as possible an |
| Quantity | 44 cases (6,336 units) (39 cases US, 5 cases OUS) |
| Distribution | US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany. |
| 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 |