Recall Z-1721-2019
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical · initiated July 13, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Codes / lots: 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.
Reason for recall
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-1721-2019
- Initiated
- July 13, 2018
- Posted by FDA
- July 5, 2019
- Terminated
- May 5, 2021
- Product code
- MED – Sterilant, Medical Devices
- 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.
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, Orange, CA