Device Recall Sarns

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 66015 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    FX 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

제조사

  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 121 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 4934
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 4934X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 4935
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 4936
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 4936X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 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
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