FDA Enforcement
Class II
Ongoing
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Recall: Z-1204-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1204-2024
- Event ID
- 93891
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Parker Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- January 22, 2024
- Classification Date
- February 29, 2024
- Address
- 286 Eldridge Rd, Fairfield, NJ, 07004-2509, United States
Description
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Reason
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
Code Info
Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
Distribution
US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
Quantity
44 cases (6,336 units) (39 cases US, 5 cases OUS)