FDA Medical Device Recalls (openFDA)
Battelle Memorial Institute: 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.
- Recall number
- Z-0309-2021
- 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.
- Status
- Terminated
- Initiated
- 2020-08-13
- Posted
- not on file
- Terminated
- 2021-02-03
- Reason
- Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
- 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 ccdscustomerservice@battelle.org
- Quantity
- 898
- Distribution
- US Nationwide distribution including in the states of CT, MA, RI.
- Lot, serial or model codes
- All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKY
- Firm FEI
- 1523658
- Firm city
- Columbus
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28