Events

Recall of Bassinet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nemschoff Chairs, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60615
  • Event Risk Class
    Class 1
  • Event Number
    Z-0832-2012
  • Event Initiated Date
    2011-10-14
  • Event Date Posted
    2012-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106002
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bassinet, hospital - Product Code NZG
  • Reason
    To correct issues with casters, door hinges, drawer slides, and the bassinet surround. also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
  • Action
    The firm, Nemschoff, sent an "Important Medical Device Correction" letter and email dated October 14, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check inventory, quarantine and hold product until they receive instructions for servicing the units; once corrections are complete on the units at their locations, document all corrections on the Correction Acknowledgment Letter and return to Nemschoff, Inc. as instructed. The customers were also instructed to complete and return the enclosed Receipt Acknowledgment Form by October 21, 2011. Nemschoff will provide instructions and assistance with locating and repairing the units. If you have any questions, call Nemschoff, Inc at (800) 203-8916 and ask for our Quality Representative or your Customer Service Representative.

Device

Bassinet
  • Model / Serial
    Model BSNT/01 and BSNT/02 manufactured between 11/21/2003 and 04/04/2008. Bassinet tubs manufactured between 11/21/2003 to present.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA,MA, MD, MI, MO, MS, NC, ND, NJ, NY, OH, OK, SC, TX, VA, WA, WI, and WY; and country of: Canada.
  • Product Description
    Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 || The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.
  • Manufacturer
    Nemschoff Chairs, Inc.

Manufacturer

Nemschoff Chairs, Inc.
  • Manufacturer Address
    Nemschoff Chairs, Inc., 909 N 8th St, Sheboygan WI 53081-4056
  • Source
    USFDA