FDA-Device2016-06-08Class II
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Natus Medical Incorporated
Hazard
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
Sold states
distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.
Affected count
21 filters
Manufactured in
5900 1st Ave S, N/A, Seattle, WA, United States
Products
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1878-2016Don't want to check this manually?
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