Recall Z-0309-2021— Battelle Memorial Institute
Class II · Terminated
Class II FDA medical device recall by Battelle Memorial Institute, initiated 2020-08-13, terminated 2021-02-03. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Battelle Memorial Institute
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-13
- Terminated
- 2021-02-03
- Firm location
- Columbus, OH, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.