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U.S. Department of Health and Human Services

Class 2 Device Recall Parker Laboratories Tensive Conductive Adhesive Gel

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  Class 2 Device Recall Parker Laboratories Tensive Conductive Adhesive Gel see related information
Date Initiated by Firm January 22, 2024
Date Posted February 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1204-2024
Recall Event ID 93891
510(K)Number K852956  
Product Classification Media, electroconductive - Product Code GYB
Product Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Code Information Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
Recalling Firm/
Manufacturer		 Parker Laboratories, Inc.
286 Eldridge Rd
Fairfield NJ 07004-2509
For Additional Information Contact Candy Beck
973-276-9500
Manufacturer Reason
for Recall		 Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GYB and Original Applicant = PARKER LABORATORIES, INC.
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