Recall Z-1721-2019— Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

Name: FDA recall Z-1721-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-13

Class II · Terminated

Class II FDA medical device recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, initiated 2018-07-13, terminated 2021-05-05. It names one FDA 510(k) clearance: K931052. Product: Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution. Reason: Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes..

Recalling firm: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Terminated: 2021-05-05
Firm location: Orange, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K931052 — METRICIDE 28Metrex Research Corp.·cleared 1994-12-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.