FDA Device recall Z-1721-2019
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution by Kerr Pentron, citing immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1721-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-13 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Kerr Pentron |
| Distribution | AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA |
Product
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Reason
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Identifiers
| code_info | Part Number: 10-6465 (McKesson Reorder # 341) Lot Numbers: 16 1250, 16 1274, 16 1324A, 16 1324B, 16 2337, 17 1038, 17…Part Number: 10-6465 (McKesson Reorder # 341) Lot Numbers: 16 1250, 16 1274, 16 1324A, 16 1324B, 16 2337, 17 1038, 17 1038A, 17 1083, 17 1193, 17 1262, 17 2122, 17 2142, 17 2219, 17 2306, 17 2347A, 18 1092B, 18 1121, 18 2037, and 18 3164. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1721-2019%22
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