FDAFDA · Food and drugs·Recall number Z-0309-2021
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.
Published November 4, 2020 · Recall initiated: August 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Battelle Memorial Institute
- Distributor
- US Nationwide distribution including in the states of CT, MA, RI.
- Lot
- All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.