LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
Publicado el 28 de mayo de 2014 · Inicio del retiro: 25 de marzo de 2014
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
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hospira Inc.
- Distribuidor
- Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates
- Lote
- List No. 6543-04-01 (6543-01); Lot Numbers: 13106NS, 13170NS, 13251NS, 14261NS, 14262NS, 15139NS, 16117NS, 17131NS, 17132NS, 17184NS, 18110NS, 18111NS, 18182NS, 19133NS, 20122NS, 20123NS, 20124NS, 20205NS, 22146NS, 22147NS, 22148NS, 22149NS, 23103NS, 23104NS, 23105NS, 23106NS, 24156NS, 25130NS, 25131NS, 27109NS, 27253NS, 27286NS, 28136NS, 28137NS, 29094NS, 29095NS, 29096NS, 30194NS, 30195NS, 30196NS, 31042NS, 31043NS, 32229NS, 32230NS, 33138NS, 33139NS, 33140NS, 34286NS, 35117NS
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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