Device Recall ARROW Edge

  • Model / Serial
    RL7085497, RL7075135, RL7024105, RL7024062, RL7013817, RL6103430, RL6083098, RL6083036, RL6062788, RL6052633, RL6022022, RL6021973, RL5090950, and RR5051996.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
  • Product Description
    ARROW Edge¿ Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

14 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot#RL7075140, RL7065024, RL7054781, RL7034393, RL7024052, RL7013831, RL6123782, RL6103334, RL6083092, RL6072882, RL6062813, RL6062783, RL6052613, RL6042444, RL6022023, RL6011960, RL5090951, and RF5054861
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
  • Product Description
    ARROW Edge¿ Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 23cm, CS-15282-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.
  • Manufacturer
  • Model / Serial
    Lot #RL7075138, RL7065026, RL7034395, RL7024054, RL7013963, RL6113593, RL6062816, RL6062772, RR5101171, RL5101008, and RF5054862.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
  • Product Description
    ARROW Edge¿ Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 27cm, CS-15322-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.
  • Manufacturer
  • Model / Serial
    Lot# RL7034396, RL6113592, RL6103341, RL6062790, RL5101009, and R5051995
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
  • Product Description
    ARROW Edge¿ Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 31cm, CS-15362-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.
  • Manufacturer
  • Model / Serial
    Lot #8016512
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
  • Product Description
    ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 31cm, ASK-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA. || The product is used for long term hemodialysis vascular access.
  • Manufacturer
  • Model / Serial
    Lot #RL7075136, RL7034391, RL6083099, RL6083037, RL6062789, RL6011934, RL5121649, RL5111321, RR5101165, RF5084348, and RF5072121
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
  • Product Description
    ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CS-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.
  • Manufacturer
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