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.
Reported: November 4, 2020 Initiated: August 13, 2020 #Z-0309-2021
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.
Details
- Recalling Firm
- Battelle Memorial Institute
- Units Affected
- 898
- Distribution
- US Nationwide distribution including in the states of CT, MA, RI.
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Battelle Memorial Institute. Units affected: 898.
Why was this product recalled? ▼
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0309-2021.
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