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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1170-2024

3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L

Publicado el 28 de febrero de 2024 · Inicio del retiro: 12 de enero de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
3M Company - Health Care Business
Distribuidor
Worldwide distribution.
Lote
UDI/DI 50707387789294 (shipper), 30707387789290 (tray), all lot codes
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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