Device Recall Sarns

  • Modèle / numéro de série
    Catalog number: 203887 and lot numbers: 0551678, 0557083, 0561754, 0562984, 0568008, 0572137, 0575072, 0580833, 0583190,0586161,0591033,0596204, 0605323, 0612587, 0615536, 0619196, 0622171,0627245,0631928,0632342, 0639031,0641468,0648454,0650700, 0652249,0653439,0660677, and 593715C.
  • 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
    SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) 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

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
    Serial numbers 5866 through 5887.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.
  • Description du dispositif
    Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. || Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.
  • Manufacturer
  • Modèle / numéro de série
    Serial numbers 1877 through 1925.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.
  • Description du dispositif
    Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S. || Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.
  • Manufacturer
  • Modèle / numéro de série
    Product Number 164275X, Serial Numbers: KP01, KP15, LA05, LA12, LA19, LC02, LC09, LC23, LD02, LD09, LD16, LD30, LE06, LE08, LE13, LE20, LE27, LE29, LF04 and LF07.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. || Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
  • Manufacturer
  • Modèle / numéro de série
    Product Number: 164275, Serial Numbers: KN10, KN26, KP08, LA05, LA12, LA19, LA22, LA26, LC12, LC16, LD16, LD23, LE01, LE15, LE22, LE29 and LF07.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units. || Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
  • Manufacturer
  • Modèle / numéro de série
    Pump manufacturing lots:  MA04 MA11 MA18 MA25 MC01 MC08 MC15 MC22 MD01 LM12 LM19 LN30 LN23 LP21 LM05 MD22 LP14A LP14 LP14AR MA04R LF04A LM26A LN02A MD29 ME05 MA11R MD15 LE13R LF04R LF11R LF18R LM26T LN02T LN09T LN16T LN23T LN30T LP07T LP14T LP21T MA04T MA11T MA11TA MA18A MA18R MA18T MA18TR MA25R MA25T MA25TA MC01T MC08T MC15T MC22T MD08 MD08T MD22T ME12 ME12T ME19 ME19T
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
  • Description du dispositif
    Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X. || CV-164275 is an item number for product that is sold to foreign affiliate. || Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures.
  • Manufacturer
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