FDA Medical Device Recalls (openFDA)
Parker Laboratories, Inc.: Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
- Recall number
- Z-1204-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-01-22
- Posted
- 2024-02-29
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
- 510(k) numbers
- ["K852956"]
- PMA numbers
- not on file
- Product code
- GYB
- Firm FEI
- 2212018
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28