Reported Nov 4, 2020 · Terminated
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating…
Battelle Memorial Institute
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Battelle Memorial Institute · 505 King Ave · Columbus, OH · 43201-2696
Is this the product you have?
- Critical Care Decontamination System (CCDS) Compatible
- N95 respirators - Product UsageUsed 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
- Lot codes and dates
- All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.
- Amount recalled
- 898
Where it was sold
Why it was recalled
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
This product could cause temporary or reversible health problems — stop using it.
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