BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1878-2016 · Initiated April 22, 2016

    Recall

    Recall Number
    Z-1878-2016
    Event Number
    74004
    Firm
    Natus Medical Incorporated
    FEI Number
    3018859
    Product Code
    LDS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2016
    Posted
    June 1, 2016
    Terminated
    December 16, 2016
    Address
    5900 1st Ave S, Seattle, WA, 98108-3248

    Description

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

    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.

    Action

    Natus sent an " URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE" Olympic Sterile Driers Model 43 & 44, Replacement HEPA Filter Contamination letter (dated April 22, 2016) was sent to all affected customers on May 2, 2016. for the first set of customers and then sent on May 12, 2016, for the second set of customers, who purchased 57 replacement filters. Customers are advised "do not install any replacement HEPA filter" if the serial number is one of the 21 shown as affected serial numbers on the letter. The URGENT RECALL NOTIFICATION/ FIELD SAFETY NOTICE Olympic Sterile Driers Model 43 & 44, Potential HEPA Filter Contamination (dated May, 2016 and released on May 12, 2016,) was sent to customers on May 16, 2016, who purchased 11 sterile driers with the installed filters. Customers are advised "do not use the Sterile drier" if it contains a HEPA filter that is identified with one of 21 affected serial numbers. Customers are advised not to install any defective replacement HEPA filters or do not use sterile drier if it currently contains defective HEPA filter. Please discontinue use of the Sterile Drier immediately if it contains defective HEPA filter as heat may cause the uncured adhesive to drip into the chamber. Customers contact Natus to obtain the RMA number and return unused filters and Natus will provide a replacement filter. Please contact Natus at [email protected] or call 866-940-7143 (option 1, Olympic products) for next steps regarding a contaminated Sterile Drier.

    Distribution

    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.

    Quantity

    21 filters