Medical device recalls Moderate risk

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Recall date
July 13, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1721-2019
FDA classification
Class II
Brand / firm
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Sold / distributed
AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

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