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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