FDAFDA · Alimentos y medicamentos·N.º oficial Z-2018-2012
MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
Publicado el 25 de julio de 2012 · Inicio del retiro: 17 de septiembre de 2009
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
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Kimberly-Clark Corporation
- Distribuidor
- Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
- Lote
- Product Code: 92354 (Secure-Fit Large), Lot #AH9141 and Product Code: 92355 (Secure Fit X-Large), Lot #AH9143. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number: 92354 (Large), Lot number range AH9072xxx to AH9175xxx; Product number: 92355 (X-Large), Lot number: AH9141 and Product number: 92358 (XX-Large), Lot number: AH9173.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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