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Recall Observatory FDA recall evidence

Device product

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

Z-1604-2024

March 22, 2024

Class II

Product summary

Firm
Parker Laboratories, Inc.
Event
Event 94303
Status
Ongoing
Classification
Class II
Quantity
217 cases (1,085 Inner Boxes; 10,850 Eaches)
Official record key
device-enforcement:Z-1604-2024

Official wording

Reason: Product demonstrates low viscosity.

Code information: 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).

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product demonstrates low viscosity.