FDAFDA · Alimentos y medicamentos·N.º oficial Z-1300-2021
In-View Clear Leggings Sterile
Publicado el 31 de marzo de 2021 · Inicio del retiro: 25 de febrero de 2021
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
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardinal Health 200, LLC
- Distribuidor
- Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and Canada.
- Lote
- Catalog Number 8430; Lot number's: 20JKS003 (expiration date:2025-09-01), 20JKS004 (expiration date:2025-09-01), 20JKS005 (expiration date:2025-09-01), 20KKS047 (expiration date:2025-10-01), 20KKS050 (expiration date:2025-10-01), 20LKS63 (expiration date:2025-11-01), 20LKS075 (expiration date:2025-11-01), and 20MKS003 (expiration date:2025-12-01).
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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