Home / Recalls / Medical Devices
Natus Medical Incorporated recalls Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and
Recalled June 8, 2016 · FDA recall Z-1878-2016 · 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. · FDA Class II
Units
21 filters
Sold at
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.
Description
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.
Product
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Manufacturer(s)
Natus Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →