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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2255-2013

King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Publicado el 25 de septiembre de 2013 · Inicio del retiro: 3 de septiembre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.

Qué hacer

Voluntary: Firm initiated · Telephone

Detalles del retiro

Fabricante
King Systems Corp.
Distribuidor
Distributed in NY.
Lote
Part Number KLTD2125 Lot Number I10RG
Clasificación de riesgo
Class III
Área (FDA)
device
País
United States