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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1901-2017

Dressing Knee/Shldr, P/N 02328 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
D163434
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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