Z-1721-2019Class II

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Name: Z-1721-2019 Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Creator: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Published: 2018-07-13
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2018-07-13 / Terminated / root cause: labeling and UDI

FDA source

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical began a recall of Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution on 2018-07-13. FDA classified it as Class II and gives the reason as "Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1721-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Posted: 2019-07-05
Terminated: 2021-05-05
Recalling firm: Sybron Dental Specialties, Inc.
Product: Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Product code: MED Sterilant, Medical Devices
Reason for recall: Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
Root cause tag: labeling and UDI
FDA 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 in commerce: 31904
Distribution: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1721-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1721-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code MED

K931052Class IIMetricide 28Metrex Research Corp. / cleared 1994-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)