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U.S. Department of Health and Human Services

Class 2 Device Recall Redux Electrolyte Creme

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 Class 2 Device Recall Redux Electrolyte Cremesee related information
Date Initiated by FirmMarch 22, 2024
Date PostedApril 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1604-2024
Recall Event ID 94303
Product Classification Media, electroconductive - Product Code GYB
ProductRedux 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).
FEI Number 2212018
Recalling Firm/
Manufacturer		 Parker Laboratories, Inc.
286 Eldridge Rd
Fairfield NJ 07004-2509
For Additional Information ContactQuality Assurance
973-276-9500 Ext. 7107
Manufacturer Reason
for Recall		Product demonstrates low viscosity.
FDA Determined
Cause 2		Process change control
ActionAn 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 Commerce217 cases (1,085 Inner Boxes; 10,850 Eaches)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
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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