FDAFDA · Alimentos y medicamentos·N.º oficial Z-0906-2020
Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
Publicado el 5 de febrero de 2020 · Inicio del retiro: 21 de octubre de 2019
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
Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Haemonetics Corporation
- Distribuidor
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB, IT, CH.
- Lote
- Catalog number/FG Item Number: 263J-SS-SET 1. Specific Lots with Bowl Cracks (110 Distributed) Lot number: 0718027-0119029-08170710119003; 0718027-0818086-08170711018045; 0718027-1118031-08170711118019; 0718027-1118081-08170710119084 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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