King LTS-D Oropharyngeal Airways Product Usage: The King LTS-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 9 de octubre de 2013 · Inicio del retiro: 12 de diciembre 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
On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- King Systems Corp.
- Distribuidor
- USA Nationwide Distribution in the state of NY
- Lote
- Part Number(s): KLTSD415 Lot Number(s): IV1V3
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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