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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2102-2014

Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava

Publicado el 30 de julio de 2014 · Inicio del retiro: 23 de mayo 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

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Terumo Cardiovascular Systems Corporation
Distribuidor
Worldwide Distribution - US (nationwide) 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.
Lote
Part No. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579, Lot #: AM001313, AM007311, AM007721, AM009067, AM016176, AM016523, AM018165; Part No. 813582, Lot #: AM001293, AM017320; Part No. 813581, Lot #: AM002694, AM003543, AM006059, AM017959; Part No. 813584, Lot #: AM001311, AM002688, AM002730, AM006055, AM016188, AM016639; Part No. 813583, Lot #: AM002729, AM006054, AM016187, AM016638, AM018071; Part No. 813586, Lot #: AM001303, AM005726, AM006061, AM008349; Part No. 813585, Lot #: AM002473, AM002728, AM006056, AM010935, AM017208; Part No. 813588, Lot #: AM002690, AM002699, AM003781, AM004252, AM006058, AM008238, AM016477; Part No. 813587, Lot #: AM001314, AM002687, AM003782, AM006057, AM008237, AM016189, AM016476, AM018297; Part No. 813590, Lot #: AM016920 & Part No. 813589, Lot #: AM002720, AM004287.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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