Device Recall Sarns

  • Modelo / Serial
    Catalog number: 203879 and lot numbers: 0558280, 0574328, 0590421, 0607092, 0613016, 0627693, 0641300, 0653436, 0655320, and 0666687.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • Descripción del producto
    SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG || Product Usage: || The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

121 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lots 19937-19944, 19955-19984, 20005-20029, 20035-20038 and 20047.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
  • Descripción del producto
    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
  • Modelo / Serial
    Lot numbers: 0629293, 0626551, 0618233, 0612412, 0608207, 0605124, 0600214, 0585956, 0582479, 0576835, 0572250, 0565377, 0557560, 0551549, 0541635, 0540864, 0537157, 0533487, 0528683, 0524211, 0519856, 0516938, 0512528, 0510871, 0509707, 0506130, 0502530, 0502218, 0501931 and 0500756.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • Descripción del producto
    Sarns Flexible Weighted Sucker, Sterile, catalog 804113, Terumo Cardiovascular Systems, Ann Arbor, MI. || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
  • Manufacturer
  • Modelo / Serial
    Lot number LK17
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • Descripción del producto
    Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
  • Manufacturer
  • Modelo / Serial
    Lot numbers: KC04, KD24, KE07, KH07, KK04, KN03, KP01, LA05, LC02, LC23, LD09, LG22, and LG22A.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • Descripción del producto
    Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack), catalog number 64789-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
  • Manufacturer
  • Modelo / Serial
    Lot numbers: KC11, KD24, KE14, and KF27.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • Descripción del producto
    Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
  • Manufacturer
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