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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2505-2021

DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only

Publicado el 29 de septiembre de 2021 · Inicio del retiro: 24 de agosto de 2021

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Potential for a wire protrusion through the left heart vent catheter tip

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Perfusion Systems
Distribuidor
Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, Yemen.
Lote
Model/Reference Number 12118, Lot Number (GTIN Number): 2018080452 (20643169086702), 2018080452 (00673978462950), 2018090435 (20643169086702), 2018090435 (00673978462950), 2018100525 (20643169086702), 2018100525 (00673978462950), 2018111024 (20643169086702), 2018111024 (00673978462950), 2018111421 (20643169086702), 2018111421 (00673978462950), 2019020369 (20643169086702), 2019020369 (00673978462950), 2019030426 (20643169086702), 2019030426 (00673978462950), 2019031168 (20643169086702), 2019031168 (00673978462950), 2019041190 (20643169086702), 2019041190 (00673978462950), 2019060424 (20643169086702), 2019060424 (00673978462950), 2019070714 (20643169086702), 2019070714 (00673978462950), 2019070715 (20643169086702), 2019070715 (00673978462950), 2019080686 (20643169086702), 2019080686 (00673978462950), 2019081292 (20643169086702), 2019081292 (00673978462950), 2019090394 (20643169086702), 2019090394 (00673978462950), 2019091081 (20643169086702), 2019091081 (00673978462950), 2019100159 (20643169086702), 2019100159 (00673978462950), 2019101446 (20643169086702), 2019101446 (00673978462950), 2019111051 (20643169086702), 2019111051 (00673978462950), 2019120418 (20643169086702), 2019120418 (00673978462950), 2020010051 (20643169086702), 2020010051 (00673978462950), 2020010446 (20643169086702), 2020010446 (00673978462950), 2020020094 (20643169086702), 2020020094 (00673978462950), 2020020764 (20643169086702), 2020020764 (00673978462950), 2020021113 (20643169086702), 2020021113 (00673978462950), 2020040403 (20643169086702), 2020040403 (00673978462950), 2020041125 (20643169086702), 2020041125 (00673978462950), 2020041431 (20643169086702), 2020041431 (00673978462950), 2020050353 (20643169086702), 2020050353 (00673978462950), 2020050919 (20643169086702), 2020050919 (00673978462950), 2020060370 (20643169086702), 2020060370 (00673978462950), 2020060673 (20643169086702), 2020060673 (00673978462950), 2020070374 (20643169086702), 2020070374 (00673978462950), 2020080075 (20643169086702), 2020080075 (00673978462950), 2020120620 (20643169086702), 2020120620 (00673978462950), 2021010035 (20643169086702), 2021010035 (00673978462950), 201906C177 (20643169086702), 201906C177 (00673978462950), 2017090238 (00673978462950), 2018080450 (20643169086702), 2018080451 (20643169086702), 2018090065 (20643169086702), 2018091021 (20643169086702), 2018100523 (20643169086702), 2018100524 (20643169086702), 2018120893 (20643169086702), 2019010457 (20643169086702), 2019010765 (20643169086702), 2019011214 (20643169086702), 2019020007 (20643169086702), 2019030064 (20643169086702), 2019030065 (20643169086702), 2019030721 (20643169086702), 2019031169 (20643169086702), 2019040844 (20643169086702), 2019040845 (20643169086702), 2019040846 (20643169086702), 2019041191 (20643169086702), 2019050167 (20643169086702), 2019050577 (20643169086702), 2019050846 (20643169086702), 2019051127 (20643169086702), 2019060219 (20643169086702), 2019060220 (20643169086702), 2019060687 (20643169086702), 2019060985 (20643169086702), 2019060986 (20643169086702), 2019070613 (20643169086702), 2019071115 (20643169086702), 2019081002 (20643169086702), 2019090072 (20643169086702), 2019090393 (20643169086702), 2019091025 (20643169086702), 2019100418 (20643169086702), 2019101095 (20643169086702), 2019110084 (20643169086702), 2019111050 (20643169086702), 2019120927 (20643169086702), 2020010052 (20643169086702), 2020011621 (20643169086702), 2020020472 (20643169086702), 2020030065 (20643169086702), 2020050354 (20643169086702), 2020050700 (20643169086702), 2020060067 (20643169086702), 2020060068 (20643169086702), 2020060964 (20643169086702), 2020060965 (20643169086702), 2020070055 (20643169086702), 2020070655 (20643169086702), 2020070969 (20643169086702), 2020071273 (20643169086702), 2020081034 (20643169086702), 2020090632 (20643169086702), 2020110762 (20643169086702), 2020120079 (20643169086702), 2020120621 (20643169086702), 2021010553 (20643169086702), 2021011168 (20643169086702), 2021011169 (20643169086702),
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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