Reported Jun 8, 2016 · Terminated

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

Natus Medical Incorporated

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: Natus Medical Incorporated · 5900 1st Ave S · Seattle, WA · 98108-3248

Is this the product you have?

  • Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44
  • Filter Catalogue Part Number
    • 54343
    • 54344
    • and 100105-01
Lot codes and dates
  • Filter Serial NumbersFilter
  • SN
    • 2522893
    • 2522897
    • 2522898
    • 2522899
    • 2522900
    • 2522903
    • 2522914
    • 2522915
    • 2522916
    • 2522917
    • 2522918
    • 2522919
    • 2522920
    • 2522921
    • 2522922
    • 2522923
    • 2522924
    • 2522925
    • 2522926
    • 2522930
    • and 2522931
Amount recalled
21 filters

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 16, 2016 · Data as of Sep 19, 6:05 PM UTC

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