Device Recall Covidien

  • Modelo / Serial
    Kit Lot numbers: 00B0203 00Z1924 00Z1992 00Z1993 00Z2030 00Z2062 00Z2063 00Z2072 00Z2081 00Z2090 00Z2098 00Z2117 00Z2119 00Z2121 00Z2122 00Z2123 00Z2124 00Z2129 00Z2130 00Z2133 00Z2138 00Z2139 00Z2143 00Z2145 00Z2146 00Z2147 00Z2148 00Z2150 00Z2151 00Z2152 00Z2153 00Z2154 00Z2155 00Z2159 00Z2160 00Z2161 00Z2163 00Z2164 00Z2166 00Z2167 00Z2171 00Z2172 00Z2174 00Z2175 00Z2176 00Z2177 00Z2179 00Z2181 00Z2182 00Z2183 00Z2184 00Z2187 00Z2190 00Z2191 00Z2192 00Z2193 00Z2194 00Z2198 00Z2199 00Z2200 00Z2201 00Z2208 00Z2209 00Z2211 00Z2212 00Z2213 00Z2216 00Z2217 00Z2220 00Z2221 00Z2222 00Z2223 00Z2224 00Z2225 00Z2233 00Z2234 00Z2237 00Z2243 00Z2244 00Z2245 00Z2249 00Z2252 00Z2254 00Z2255 00Z2265 00Z2268 00Z2272 00Z2273 00Z2287 00Z2289 00Z2304 00Z2305 00Z2306 00Z2312 00Z2315 00Z2321 00Z2322 00Z2323 00Z2325 00Z2326 00Z2327 00Z2328 00Z2351 00Z2352 00Z2353 00Z2367 00Z2391 00Z2392 00Z2396 00Z2432 00Z5001 00Z5001A BARIATRICRR1 BARIATRICRR5 BARIATRICRR7 ENDOBARIATRICR ENDOBARIATRICS ENDOTHORACICL ENDOTHORACICS ENDOTHORACICW THORACICRR1 00Z2363 00Z2364 00Z2387
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.
  • Descripción del producto
    Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles || Product Usage: || The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

76 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Codes: 511752564X 516054164X 520853264X 525450264X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover P400 UM 18FR SIL COUDE SECURE || Item Code: P4P18CSDK || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Codes: 520857564X 522553864X 522958164X 523656864X 525153364X 525755664X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover P400 PREM U/M 18FR SIL FLY || Item Code: P4P18SD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Codes: 516050964X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover P400 PREM U/M 18FR UL FOLY CSD || Item Code: P4P18ULD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Codes:  511851364X 512550364X 515357964X 518150364X 520150964X 523656964X 524356864X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) and to Canada.
  • Descripción del producto
    Covidien Dover PREC PRM 16FR SILVER FLY TY || Item Code: PP16XSD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • Modelo / Serial
    Lot Code: 521807764X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
  • Descripción del producto
    Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. || Intended for pediatric feeding.
  • Manufacturer
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