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Recall Observatory FDA recall evidence

Device product

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

Z-1878-2016

April 22, 2016

Class II

Product summary

Firm
Natus Medical Incorporated
Event
Event 74004
Status
Terminated
Classification
Class II
Quantity
21 filters
Official record key
device-enforcement:Z-1878-2016

Official wording

Reason: 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.

Code information: 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, and 2522931.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.