FDA Device recall Z-0309-2021
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2…
- FDA Device
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2… by Battelle Memorial Institute, citing masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0309-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-13 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Battelle Memorial Institute |
| Distribution | US |
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
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Identifiers
| code_info | All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2021%22
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