Recall Z-1604-2024 ยท GYB Media, Electroconductive
Parker Laboratories, Inc.
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
| Date | Apr 19, 2024 (initiated Mar 22, 2024) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.