FDAFDA · Alimentos y medicamentos·N.º oficial Z-0183-2021
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)4603240;(01)10887709051024(17)250201(30)50(10)4714349; (01)10887709051024(17)250201(30)50(10)4733540; (01)10887709051024(17)250201(30)50(10)4724812; (01)10887709051024(17)241201(30)50(10)4515226; (01)10887709051024(17)241201(30)50(10)4537113; (01)10887709051024(17)250101(30)50(10)4557474; (01)10887709051024(17)250201(30)50(10)4718500; (01)10887709052793(17)250101(30)50(10)4557476; (01)10887709052793(17)250101(30)50(10)4590957; The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
Publicado el 28 de octubre de 2020 · Inicio del retiro: 6 de julio de 2020
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
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- ICU Medical, Inc.
- Distribuidor
- Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
- Lote
- Lot Numbers: 4603240, 4714349,4733540,4724812, 4515226, 4537113, 4557474, 4718500, 4557476,4590957.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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