Device product
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Z-1721-2019
Product summary
- Event
- Event 82553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31904
- Official record key
device-enforcement:Z-1721-2019
Official wording
Reason: Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Code information: 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.
Distribution pattern: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
Derived failure modes
-
Unknown
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.