Recall record at a glance
| Official record | Z-0309-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Battelle Memorial Institute |
| Report date | Nov 4, 2020 |
| Recall initiation date | Aug 13, 2020 |
| Quantity | 898 |
| Location | Columbus, OH, United States |
Official 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.
Why the product was recalled
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Distribution information
US Nationwide distribution including in the states of CT, MA, RI.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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