Natus Medical Incorporated recalls Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and…

Recall date

April 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1878-2016

FDA classification

Class II

Brand / firm

Natus Medical Incorporated

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.