FDA recall Z-1721-2019
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical · Class II · device
Product
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Reason for recall
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Distribution
AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
Key facts
- Status
- Terminated
- Initiation date
- 2018-07-13
- Report date
- 2019-06-12
- Termination date
- 2021-05-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Orange, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1721-2019