Recall Z-1721-2019 ยท MED Sterilant, Medical Devices
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
| Date | Jul 5, 2019 (initiated Jul 13, 2018) |
| Status | Terminated |
| Reason | Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. |
| Root cause | Error in labeling |
| Action | On July 13, 2018, Metrex Research Corp., a subsidiary of Kerr Corporation, sent URGENT NOTICE: Regimen Glutaraldehyde letters to their consignees instructing them to check their inventory and complete the enclosed Field Action Acknowledement and Product Return Form. Distributors were requested to conduct sub-recalls to their consignees. |
| Quantity | 31904 |
| Distribution | AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931052 | METRICIDE 28 Metrex Research Corp., Dec 6, 1994 |