Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1… recallZ-1204-2024 · Parker Laboratories, Inc. · initiated Jan 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Parker Laboratories, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
FDA root cause category: Under Investigation by firm
What the company is doing
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: [email protected], 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 [email protected] or 973-276-9500 ext. 7107.
Recall details
- Recall number
- Z-1204-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 22, 2024
- Posted by the FDA
- Feb 29, 2024
- Recalling firm
- Parker Laboratories, Inc.
- Quantity
- 44 cases (6,336 units) (39 cases US, 5 cases OUS)
- Product code
- GYB
- FDA submissions
- K852956
- Distribution
- US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
Product description
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Code information (models, lots, serial numbers)
Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TENSIVE CONDUCTIVE ADHESIVE GELParker Laboratories Inc · Media, Electroconductive2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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