FDA recall Z-0309-2021

Battelle Memorial Institute · Class II · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-08-13
Report date
2020-11-04
Termination date
2021-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0309-2021