Z-0309-2021Class II

Critical Care Decontamination System (CCDS) Compatible N95 respirators -

Name: Z-0309-2021 Critical Care Decontamination System (CCDS) Compatible N95 respirators -
Creator: Battelle Memorial Institute
Published: 2020-08-13
License: https://open.fda.gov/license/

Battelle Memorial Institute / initiated 2020-08-13 / Terminated

FDA source

Battelle Memorial Institute began a recall of Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3... on 2020-08-13. FDA classified it as Class II and gives the reason as "Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0309-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-13
Posted: 2020-10-29
Terminated: 2021-02-03
Recalling firm: Battelle Memorial Institute
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.
Product code: QKY Decontamination Systems For N95 Respirators
Reason for recall: Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
FDA root cause: Under Investigation by firm
Action: Customers were notified via email on 8/13/20: Dear CCDSTM Customer, Recently, we became aware that masks processed at the Providence, RI CCDSTM site were not maintained at levels of condensation during a portion of the decontamination cycle. The first phase (gassing phase) operated as intended. The next phase (dwell phase) had a gradual decline of condensation. The CCDSTM team has corrected this and has confirmed that the system is operating correctly. The normal CCDSTM decontamination cycles operate above the levels of regulatory guidelines. To ensure that our process decontaminated the masks effectively, our research team replicated this process cycle, including the deviated dwell phase, with a similar number of masks in the chamber. As expected, the results showed a 6-log reduction. Though this was a deviation to an internal operating procedure, out of caution, we are asking you to return your masks to the CCDSTM site to be reprocessed. We will send you replacement masks if you need them while your masks are being decontaminated. Battelle CCDSTM is committed to maintaining the highest standards for our customers. Please contact us with any questions. Sincerely, Battelle CCDSTM Team Call us at 614-424-4373 [email protected]
Quantity in commerce: 898
Distribution: US Nationwide distribution including in the states of CT, MA, RI.
Product codes and lots: All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0309-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0309-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-29

Product code QKY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)