Z-1204-2024Class II

Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes...

Name: Z-1204-2024 Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes...
Creator: Parker Laboratories, Inc.
Published: 2024-01-22
License: https://open.fda.gov/license/

Parker Laboratories, Inc. / initiated 2024-01-22 / Open, Classified

FDA source

Parker Laboratories, Inc. began a recall of Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each on 2024-01-22. FDA classified it as Class II and gives the reason as "Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1204-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-22
Posted: 2024-02-29
Recalling firm: Parker Laboratories, Inc.
Product: Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Product code: GYB Media, Electroconductive
Reason for recall: Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1204-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1204-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29

Product code GYB

K852956Class IIContact Conductive Adhesive Gel CompositionParker Laboratories, Inc. / cleared 1985-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)