Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Summary
The FDA issued a Class II for Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inne by Parker Laboratories, Inc.. Reason: Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60..
Details
Source
Device Recall
External ID
Z-1204-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Lot/Code Info: Product Number: 22-60; UDI/DI: (Master)20855683006337, (Inner Box) 10855683006330, (Individual Unit) 00855683006333; Lot A0623009.
Quantity Affected: 44 cases (6,336 units) (39 cases US, 5 cases OUS)
Reason for Recall
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
Distribution
US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada, France and Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-22
Company
Fairfield, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Parker Laboratories, Inc. has 8 FDA actions in our database, including 7 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Parker Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Parker Laboratories, Inc. have FDA actions?
Parker Laboratories, Inc. has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1204-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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