Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1604-2024Class II

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

Parker Laboratories, Inc. / initiated 2024-03-22 / Open, Classified

Parker Laboratories, Inc. began a recall of Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme on . FDA classified it as Class II and gives the reason as "Product demonstrates low viscosity". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1604-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Parker Laboratories, Inc.
Product
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Product code
GYB Media, Electroconductive
Reason for recall
Product demonstrates low viscosity.
FDA root cause
Process change control
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.
Quantity in commerce
217 cases (1,085 Inner Boxes; 10,850 Eaches)
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.
Product codes and lots
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).

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1604-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1604-2024Class IIOngoingVoluntary: Firm initiated