Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
This recall is currently active, issued February 29, 2024. It was issued by Parker Laboratories, Inc..
- Company
- Parker Laboratories, Inc.
- Recall Initiated
- January 22, 2024
- Posted
- February 29, 2024
- Recall Number
- Z-1204-2024
- Quantity
- 44 cases (6,336 units) (39 cases US, 5 cases OUS)
- Firm Location
- Fairfield, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
Distribution
US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
Lot / Code Info
Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
Root Cause
Under Investigation by firm
Action Taken
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 and return it to us at the email: ParkerQA@parkerlabs.com, mailing address: Parker Quality Representative, 4 Sperry Road, Fairfield NJ 07004, or fax number: 973.276.9500 ext 7107 on the form, so that further arrangements can be made. Parker Laboratories will make arrangements for you to return any affected product remaining in your inventory. If you have any questions, please email or call at ParkerQA@parkerlabs.com or 973-276-9500 ext. 7107.