Z-1604-2024Class II
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme
Parker Laboratories, Inc. / initiated 2024-03-22 / Open, Classified
Parker Laboratories, Inc. began a recall of Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme on . FDA classified it as Class II and gives the reason as "Product demonstrates low viscosity". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1604-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Parker Laboratories, Inc.
- Product
- Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
- Product code
- GYB Media, Electroconductive
- Reason for recall
- Product demonstrates low viscosity.
- FDA 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 [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.
- 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.
- Product codes and lots
- 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).
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1604-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
