Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical: Medical Device Recall in 2019 - (Recall #: Z-1721-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Product Classification:

Class II

Date Initiated: July 13, 2018
Date Posted: June 12, 2019
Recall Number: Z-1721-2019
Event ID: 82553
Reason for Recall:

Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

Status: Terminated
Product Quantity: 31904
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.

Voluntary or Mandated:

Voluntary: Firm initiated