Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Summary
The FDA issued a Class II for Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte crem by Parker Laboratories, Inc.. Reason: Product demonstrates low viscosity..
Details
Source
Device Recall
External ID
Z-1604-2024
Action Date
2024-05-01
Status
Ongoing
Category
device
Product Description
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Lot/Code Info: Product No. 66-04; UDI: 20855683006399 (Master), 10855683006392 (Inner Box), 00855683006395 (Each); Lot No. (Expiration Date): A1122010 (11/29/25) and A0523002 (5/12/26).
Quantity Affected: 217 cases (1,085 Inner Boxes; 10,850 Eaches)
Reason for Recall
Product demonstrates low viscosity.
Distribution
Worldwide distribution - US Nationwide in the states of CA, CO, FL, GA, IL, MD, MI, MN, NC, NE, NY, OH, PA, SC, & TX. The countries of AU, CA, OM, & SA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-22
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 203 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-1604-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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