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

FDA device recall Z-1204-2024 · posted 2024-02-29 · Open, Classified

Recall details

Recalling firm

Parker Laboratories, Inc.

Reason for recall

Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GYB

Quantity affected

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.

Date initiated

2024-01-22

Date posted

2024-02-29

Location

Fairfield, NJ

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