Z-0309-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- August 13, 2020
- Termination Date
- February 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 898
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.
Distribution Pattern
US Nationwide distribution including in the states of CT, MA, RI.
Code Information
All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.