FDAFDA · Alimentos y medicamentos·N.º oficial Z-1904-2017
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Publicado el 10 de mayo de 2017 · Inicio del retiro: 30 de marzo de 2017
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
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Breg Inc
- Distribuidor
- US Nationwide Distribution
- Lote
- D163424, D163474
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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