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Redux Electrolyte Creme, Product Ref. 66-04. Highly… recallZ-1604-2024 · Parker Laboratories, Inc. · initiated Mar 22, 2024

Class II Open, Classified All recalls posted in April 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Parker Laboratories, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product demonstrates low viscosity.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-1604-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Mar 22, 2024
Posted by the FDA
Apr 19, 2024
Recalling firm
Parker Laboratories, Inc.
Quantity
217 cases (1,085 Inner Boxes; 10,850 Eaches)
Product code
GYB
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 description

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

Code information (models, lots, serial numbers)

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).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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