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Terminated

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

FDA Recall Z-1721-2019 · Posted 2019-07-05

Recalling FirmKerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Recall StatusTerminated
Product CodeMED
Date Initiated2018-07-13
Date Terminated2021-05-05
Product Quantity31904

Reason for Recall

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

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931052METRICIDE 28Metrex Research Corp. · 1994-12-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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