# FDA recall Z-0309-2021

> **Battelle Memorial Institute** · Class II · device recall initiated 2020-08-13.

## 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

- **Recall number:** Z-0309-2021
- **Recalling firm:** Battelle Memorial Institute
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0309-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0309-2021. Source: US FDA. Licensed CC0.

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