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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2329-2016

6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.

Publicado el 10 de agosto de 2016 · Inicio del retiro: 13 de julio 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

A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
AccessClosure, Inc., A Cardinal Health Company
Distribuidor
US in the states of CA, and MS.
Lote
Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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