FDA Medical Device Recalls (openFDA)
Parker Laboratories, Inc.: Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
- Recall number
- Z-1604-2024
- Recalling firm
- Parker Laboratories, Inc.
- Product
- Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
- Status
- Open, Classified
- Initiated
- 2024-03-22
- Posted
- 2024-04-19
- Terminated
- not on file
- Reason
- Product demonstrates low viscosity.
- 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 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
- 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.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GYB
- Firm FEI
- 2212018
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28