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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1452-2014

Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.

Publicado el 16 de abril de 2014 · Inicio del retiro: 25 de marzo de 2014

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

Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Dr¿ger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. A

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Draeger Medical, Inc.
Distribuidor
USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD, MO, IA, TN, MD, WV, IL,NJ, CT, and AR.
Lote
Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, and reusable anaesthesia sets part numbers M33681 and M27542.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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