Device Recall Percutaneous Sheath Introducer Kit

  • Modèle / numéro de série
    510K # K061289; Material numbers: EU-04041-HPMSB, EU-04052-HPMSB, EU-05041-HPMSB, and EU-05052-HPMSB.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Arrow Pressure Injectable PICC Kit || The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
  • Source
    USFDA

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Material number ASK-09801-ST
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters || The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation
  • Manufacturer
  • Modèle / numéro de série
    Material number ASK-29803-MM
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters || The Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The ARROWg+ard¿ antimicrobial surface is intended to help provide protection against sheath-related infections. The sheath is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
  • Manufacturer
  • Modèle / numéro de série
    ASK-09903-ECL 23F16H0387 23F16H0595
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. || Catheters. || Permits venous access and catheter introduction to the central circulation.
  • Manufacturer
  • Modèle / numéro de série
    Product number ASK-29803-SJH. Lot numbers RF9044900 and RF9068155
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The products were shipped to distributors in GA, MD, and VA.
  • Description du dispositif
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
  • Manufacturer
  • Modèle / numéro de série
    Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
  • Description du dispositif
    Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
  • Manufacturer