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

FDA device recall Z-1604-2024 · posted 2024-04-19 · Open, Classified

Recall details

Recalling firm

Parker Laboratories, Inc.

Reason for recall

Product demonstrates low viscosity.

Action taken

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 ParkerQA@parkerlabs.com 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

Status

Open, Classified

Product code

GYB

Quantity affected

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.

Date initiated

2024-03-22

Date posted

2024-04-19

Location

Fairfield, NJ