Device Recall Sarns

  • Modèle / numéro de série
    Catalog number: 71619 and lot number: ND14 and NE11.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    X-COATED TRANSPLANT PACK || 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

Fabricant

  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
  • Source
    USFDA

121 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
  • Description du dispositif
    Sarns " TCM II Temperature Control Module || The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number 4934
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
  • Description du dispositif
    Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long || The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number 4934X
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
  • Description du dispositif
    Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating || The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number 4935
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
  • Description du dispositif
    Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long || The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number 4936
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
  • Description du dispositif
    Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long || The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
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