ISSUE: FDA notified healthcare professionals and medical care organizations about the Class 1 recall of this pediatric hospital bed (bassinet) product in order to correct issues with the wheels (casters), door hinges and drawer slides on the cart’s frame. The doors and drawers may inadvertently open while the bassinet is in motion and the product may be difficult to maneuver due to its swivel caster configuration. If either of these events were to occur, there is the potential for injury to the patient, including death and other serious health consequences.
BACKGROUND: The bassinet is intended for medical purposes for the individual care of infants. The cart’s frame can include drawers, shelving or cabinetry and the wheels (casters) located under the cart allow for infant transportation through out the health care facility. Models BSNT/01 and BSNT/02 were manufactured between 11/2003 and 02/2008. Models BSNT/03 and BSNT/04 were manufactured between 11/21/2003 to present.
RECOMMENDATIONS: Nemschoff sent an “Important Medical Correction” letter and email on October, 14, 2011 to its customers. The letter described the product, problem, and action to be taken. The customers were instructed to check their inventory, isolate and hold product until they receive instructions for servicing the units. Customers with further questions should contact Nemschoff Chair at 800-203-8916 and ask for the Quality Representative and Customer Service Representative.