Z-1721-2019 Class II Terminated
FDA device recall Z-1721-2019 was initiated by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical on July 13, 2018 and is designated Class II. Reason for recall: Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. The recall status is terminated (terminated May 5, 2021). Affected quantity: 31904.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- July 13, 2018
- Termination Date
- May 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31904
Product Description
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 Pattern
AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
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.