FDAFDA · Alimentos y medicamentos·N.º oficial Z-2916-2020
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
Publicado el 9 de septiembre de 2020 · Inicio del retiro: 29 de julio de 2020
Estado reportado al momento de publicación: Completed — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardinal Health 200, LLC
- Distribuidor
- US Nationwide distribution
- Lote
- Item Code: 2D72NT75X Lot #: TS19060031, TS19060065, TS19060168, TS19060302, TS19080080, TS19080176, TS19080203, TS19080262, TS19090027, TS19090064, TS19090167, TS19090272, TS19100111, TS19100197, TS19100244, TS19100262, TS19110041, TS19110102, TS19110176, TS19110238, TS19120002, TS19120044, TS19120274, TS20020286, TS20030288, TS20040030, TS20040086, TS20050114 Additional Affected Lots as of 10/20/20: TS20040051, TS20040075, TS20040058, TS20040176, TS20040280, TS20040281, TS20040291, TS20050010, TS20050174, TS20050306, TS20050353, TS20060032, TS20060038, TS20060120, TS20060174, TS20060175, TS20060260, TS20050250
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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