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Open, Classified

Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.

FDA Recall Z-1604-2024 · Posted 2024-04-19

Recalling FirmParker Laboratories, Inc.
Recall StatusOpen, Classified
Product CodeGYB
Date Initiated2024-03-22
Product Quantity217 cases (1,085 Inner Boxes; 10,850 Eaches)

Reason for Recall

Product demonstrates low viscosity.

Firm Action

An URGENT MEDICAL DEVICE RECALL notification, dated 3/19/24, was emailed to consignees notifying them of this recall. Consignees were asked to examine their inventory for affected devices, quarantine devices identified as part of this recall and discontinue use, and return the email acknowledgement and Recall Stock Response Form to the firm. If product was further distributed, consignees are to conduct their own sub-recalls of affected devices. Consignees with any questions can contact Parker Laboratories by email at [email protected] or by phone at 973-276-9500x7107 from Monday through Thursday, from 8:30 AM to 5:00 PM, or Friday from 8:30 AM to 1:00 PM.

Root Cause

Process change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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