Devices

Device Recall OriGen

  • 모델명 / 제조번호(시리얼번호)
    Model V V 12F; Lot Number 36BC20121
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany.
  • 제품 설명
    Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744
  • Manufacturer
    Origen Biomedical, Inc
  • 1 Event

제조사

Origen Biomedical, Inc
  • 제조사 주소
    Origen Biomedical, Inc, 4020 S Industrial Dr Ste 160, Austin TX 78744-1080
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Origen DBM with Bioactive Glass
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 22-2002 Lot #: 070281P, 070591P, 073221P, 073434P, 073504P, 073577PA, 073761PA, 073761PB, 074349P, 075075PA, 075128P, 075245PA, 075255P, 075259P, 077870PA, 078093PB, 078268PB.   Catalog # 22-2005 Lot #: 067559PA, 067559PB, 0700869, 070281P, 070546PA, 070546PB, 070552P, 070591P, 070743P, 070884PA, 070884PB, 073221P, 073222P, 073346PB, 073434P, 073496P, 073504P, 074032P, 075075PB, 075259P, 075481P, 075637PA, 075637PB, 075660P, 077642PA, 077870PB, 078048P, 078268PB, 078309PA, 079002PA.   Catalog # 22-2010 Lot #: 060095P, 067484P, 070203P, 070281P, 070512P, 070521P, 070603PA, 070607P, 070629P, 070703P, 070704P, 070755P, 070831P, 070916P, 071043PB, 071045PA, 071053PA, 071053PB, 073221P, 073319PB, 073346PA, 073346PB, 073411PB, 073434P, 073494PA, 073494PB, 073502P, 073590P, 073695P, 073751P, 073828P, 073879P, 075050PA, 075058P, 075167PB, 075230PA, 075230PB, 075245PB, 075338PA, 075338PB, 075492PA, 075629P, 077390P, 077715PA, 077715PB, 077863PA, 078093PA, 078268PA, 078268PB, 078344PB.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
  • 제품 설명
    Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" || Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" || Origen DBM with Bioactive Glass Catalog #: || 22-2002 (2cc size) || 22-2005 (5cc size) || 22-2010 (10cc size) || "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." || Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
  • Manufacturer
    Nanotherapeutics, Inc
Device Recall Origen DBM with Bioactive Glass
  • 모델명 / 제조번호(시리얼번호)
    Catalog # NAN109-02, Lot #: 074349P.  Catalog # NAN109-05, Lot #: 073995PA, 077870PB.  Catalog # NAN109-10, Lot #: 071045PB, 071043PA, 070916P.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
  • 제품 설명
    Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" || Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" || NanoFUSE DBM Catalog #: || NAN109-02 (2cc size) || NAN109-05 (5cc size) || NAN109-10(10cc size) || "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." || Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
  • Manufacturer
    Nanotherapeutics, Inc