Drug recall
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in…
FDA recall event 86347 · Class II · Battelle Memorial Institute
Key facts
| Event ID | 86347 |
|---|---|
| Recall numbers | Z-0309-2021 |
| Recalling firm | Battelle Memorial Institute |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle. |
| Initiation date | Aug 13, 2020 |
| Report date | Nov 4, 2020 |
| Termination date | Feb 3, 2021 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 1523658 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: