FDA Medical Device Recalls (openFDA)
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical: Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
- Recall number
- Z-1721-2019
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Product
- Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
- Status
- Terminated
- Initiated
- 2018-07-13
- Posted
- 2019-07-05
- Terminated
- 2021-05-05
- Reason
- Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
- Root cause
- Error in labeling
- Action
- 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.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K931052"]
- PMA numbers
- not on file
- Product code
- MED
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28