Battelle Memorial Institute recalls Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compati…

Recall date

August 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0309-2021

FDA classification

Class II

Brand / firm

Battelle Memorial Institute

Sold / distributed

US Nationwide distribution including in the states of CT, MA, RI.

Why it was recalled

Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

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

What was recalled

Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.