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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2002-2016

Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

Publicado el 22 de junio de 2016 · Inicio del retiro: 9 de mayo de 2016

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

Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Datascope Corporation
Distribuidor
US in the state of GA
Lote
Lot/batch No: 3000003260, Part number 701050175
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States