FDAFDA · Alimentos y medicamentos·N.º oficial Z-2913-2020
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - 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: 2D72NT60X Lot #: TS19060043, TS19060123, TS19060199, TS19070005, TS19070027, TS19070067, TS19070130, TS19070179, TS19070273, TS19080030, TS19090067, TS19090158, TS19090226, TS19090289, TS19110333, TS19120019, TS19120322, TS20020121, TS20030015, TS20030324 Additional Affected Lots as of 10/20/20: TS20040173, TS20040249, TS20040257, TS20040333, TS20050052, TS20050069, TS20050152, TS20050153, TS20050196, TS20050197, TS20050334, TS20050335, TS20060011, TS20060053, TS20060054, TS20060115, TS20060116, TS20060199, TS20060200, TS20060250, TS20070023, TS20070108, TS20070183
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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