medical Class II Updated 2020-11-04

Battelle Memorial Institute recalls Critical Care Decontamination System (CCDS) Compatible N95

Recalled 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.


Hazard / Issue

Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
View official government recall

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