High FDA (Devices)·Z-1878-2016·Announced 2016-06-08

Natus Medical Recalls Replacement HEPA Filters for Sterile-Driers

Natus Medical is recalling 21 replacement HEPA filters for Sterile-Driers because improperly cured sealant may emit toxic gas or drip, contaminating the device.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of harm (toxic gas emission and contamination) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Natus Medical Incorporated is recalling 21 replacement HEPA filters used in Natus Sterile-Drier Model 43 and Model 44 units. The affected filters have catalogue part numbers 54343, 54344, and 100105-01, and specific serial numbers ranging from 2522893 to 2522931.

The recall was initiated because the filters were 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. This poses a risk of contaminating the interior chamber of the Sterile Drier and its contents.

The affected filters were distributed in the United States, including Arizona, California, Florida, Illinois, Kansas, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Virginia, Washington, Washington DC, and Wisconsin, as well as in Canada and Singapore. Users should stop using the affected filters and contact Natus Medical Incorporated for instructions on replacement or return.

The recalled product

Product: Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Manufacturer: Natus Medical Incorporated
Category: Medical Device — Sterilization Equipment
Hazard: toxic-gas-emission
contamination
Affected units: 21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Filter Serial Numbers: Filter SN: 2522893
2522897
2522898
2522899
2522900
2522903
2522914
2522915
2522916
2522917
2522918
2522919
2522920
2522921
2522922
2522923
2522924
2522925
2522926
2522930

Distribution

Distributed in 18 states:

Same manufacturer · Natus Medical Incorporated

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