FDAAugust 13, 2020device
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 suppli...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
What to do
FDA enforcement status: Terminated
Brands named
battelle memorial institutebattellebattelle memorial
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEclectic Herb Vitamin Herb Blend vita biotic dietary supplement, 750mg, 150 capsules per plastic bottle, UPC 0 23363 52002 2. Eclectic Institute, Inc. 755 NE 6th Street Gresham, OR 97030. The affected label declared "Oregon Grape 190mg ***Oregon Grape 97mg***Cayenne Root (Allium sativum) 195mg **...2022-08-03
- FDACarrot cake (no brand), 6 inch and 8 inch sizes, on plastic base, with clear plastic dome. UPC code: 8 13749 01001 4 6-inch cake 8 50024 83623 5 8-inch cake2021-08-31
- FDAAll Day Energy Greens Fruity (ADEGF), Great Fruity Taste!, Net Wt 10.5 oz (299g), UPC Code 893320002096 and 893320002423.2016-03-11
- FDAAll Day Energy Greens (ADEG), Original Flavor, Net Wt 11.36 oz (322g), UPC Code 8933200020962016-03-11
- FDAPF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF...2014-12-15
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