BEUDAMED
    FDA Recall Terminated

    Naera Hospital Bassinet, Model No. 4402

    Recall: Z-0813-2019 · Initiated October 10, 2018

    Recall

    Recall Number
    Z-0813-2019
    Event Number
    81393
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    NZG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 10, 2018
    Posted
    February 7, 2019
    Terminated
    April 29, 2020
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    Naera Hospital Bassinet, Model No. 4402

    Reason

    It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.

    Action

    The firm notified customers on October 10, 2018, via Urgent Medical Device Recall letters. The letters informed users of the issue with the mattress component of the bassinet. Customers were instructed to do the following: 1. Find the serial numbers listed on the attached business reply form and be sure you know where they are located at your facility. 2. Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email [email protected]. 3. Inspect the Nra bassinets at your location. If any exhibit the condition as shown in the Product issue section of this letter, please quarantine the unit, remove it from service, and contact Stryker at 269 389 8306. 4. One of Strykers representatives will contact you to schedule the replacement of the mattresses in all affected units at your location. 5. If you have questions regarding the continued safe use of your product, please contact Technical Support by calling +1 800 327 0770 and selecting opt 2. 6. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 7. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. If you have any questions or concerns, please contact Customer Service +1 800 327 0770. The firm's normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

    Distribution

    Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico.

    Quantity

    5915