A Class I recall has been announced for Nemschoff Chairs Perinatal Pediatric Hospital Beds (Bassinet) over risk of patient injury, the U.S. Food and Drug Administration (FDA) just announced. A Class I recall is the agency’s most serious and indicates that the recalled product may cause serious adverse health consequences, including death.
The bassinet is intended for medical purposes for the individual care of newborns and infants. The defective bassinet consists of an infant tray with mattress, which sits on top of a wheeled cart, and may include a tub for bathing. The cart’s frame can include drawers, shelving, or cabinetry and the wheels (casters), which are located under the cart to allow for infant transportation throughout the health care facility.
The agency said it 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 and the acrylic bassinet tub. 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. Either of these events enables the potential for patient injury, including death and other serious health consequences.
The manufacturer also added labeling to the products regarding drawer weight limits, and specific instructions for cleaning the bassinet tub.
The model numbers and manufacture dates involved are:
• Models BSNT/01 and BSNT/02: Manufactured between 11/2003 and 02/2008.
• Models BSNT/03 and BSNT/04: Manufactured between 11/21/2003 to present.
Nemschoff, Inc. sent an “Important Medical Correction” letter and email on October, 14, 2011 to its customers, which can be accessed at: http://www.fda.gov/downloads/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/UCM293214.pdf. The letter described the product, problem, and required action. Customers were instructed to check their inventory and isolate and hold the bassinet until they receive instructions for servicing the units. Customers were also instructed to document all corrections on the Correction Acknowledgement Letter once corrections are complete on the units at their locations, and to return the letter to Nemschoff, Inc. Customers were also advised to have completed and returned the Receipt Acknowledgement Form by October 21, 2011.
Nemschoff, Inc. advised that it would provide instructions and assistance with locating and repairing the units.
Nemschoff Chair can be reached, toll-free, at 1.800.203.8916; ask for the Quality Representative and Customer Service Representative. Nemschoff Chairs, Inc. is located at 909 N 8th Street, Sheboygan, Wisconsin, 53081-4056.