Device Recall Sarns

  • Model / Serial
    Catalog number: 203895 and lot numbers: 0551294, 0555085, 0557607, 0560171, 0563852, 0568020, 0572133, 0579089, 0586166, 0592735, 0598461, 0603720, 0611573, 0616893, 0619181, 0625003, 0633298, 0637811, 0640423, 0645344, 0649186, 0652248, 0655897, 0662813, and 621706C.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE 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

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

121 devices with a similar name

Learn more about the data here

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
  • Product Description
    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
  • Model / Serial
    lots 19945-19954 and 19985-20001.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
  • Product Description
    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
  • Manufacturer
  • Model / Serial
    Lots 19937-19944, 19955-19984, 20005-20029, 20035-20038 and 20047.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
  • Product Description
    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
  • Model / 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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • Product Description
    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
  • Model / Serial
    Lot number LK17
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • Product Description
    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
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