Device Recall Bard

  • Modèle / numéro de série
    Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units).  Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA, MA
  • Description du dispositif
    Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
  • Source
    USFDA

81 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Code: 43JQD016
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide
  • Description du dispositif
    Bard 3D Max Mesh, Left large , Sterile || Pre-formed Knitted Polypropylene || Product Code: 0151531 || Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: ANSH0293.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Description du dispositif
    Bard E LUMINEXX Biliary Stent,Size: 6mm x 20mm, Product Number: ZBM06020.
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: ANSG2286.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Description du dispositif
    Bard E LUMINEXX Biliary Stent, Size: 6mm x 30mm, Product Number: ZBM06030.
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: ANSH0294 and ANSI0239.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Description du dispositif
    Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBM06040.
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: ANSJ0893.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Description du dispositif
    Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.
  • Manufacturer
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