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Class 2 Device Recall Redux Electrolyte Creme |
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Date Initiated by Firm |
March 22, 2024 |
Date Posted |
April 19, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1604-2024 |
Recall Event ID |
94303 |
Product Classification |
Media, electroconductive - Product Code GYB
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Product |
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme. |
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). |
Recalling Firm/ Manufacturer |
Parker Laboratories, Inc. 286 Eldridge Rd Fairfield NJ 07004-2509
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For Additional Information Contact |
Quality Assurance 973-276-9500 Ext. 7107
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Manufacturer Reason for Recall |
Product demonstrates low viscosity.
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FDA Determined Cause 2 |
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 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. |
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.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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