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.
Z-0309-2021
Product summary
- Event
- Event 86347
- Status
- Terminated
- Classification
- Class II
- Quantity
- 898
- Official record key
device-enforcement:Z-0309-2021
Official wording
Reason: Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Code information: All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
Distribution pattern: US Nationwide distribution including in the states of CT, MA, RI.
Derived failure modes
-
Unknown
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.