The Recall Desk

FDA (Devices) recall action 76937

Arrow International Inc recalled 56 products on 2017-06-14

The FDA (Devices) publishes a recall like this one as 56 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 56 pages.

Products
56
Announced
2017-06-14
Critical
0
Units
1,909,336

Why these products were recalled

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard Blue antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue antimicrobial surface in de…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–50 of 56

  • HighFDA (Devices)··2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited…
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow PICC Kit Recalled Due to BD Eclipse Needle Safety Cover Issues

    Arrow International is recalling certain PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment…
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Arterial Catheterization Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Arterial Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Femoral Arterial Line Catheterization Kits

    Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
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    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk

    Arrow International is recalling specific large-bore central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Central Catheters Due to Needlestick Injury Risk

    Arrow International is recalling 43,394 units of central catheters because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
    Category
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow PICC Recall Initiated Due to Needlestick Injury Risk

    Arrow International is recalling 43,394 units of Arrow PICC with Chlorag+ard Technology due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.

    Product
    Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow VPS Access Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling VPS Access Kits due to safety cover disengagement on packaged BD Eclipse Needles, posing a needlestick injury risk.

    Product
    Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling specific Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    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
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    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…
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Central Catheters Due to Needlestick Injury Risk

    Arrow International is recalling specific central catheters because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    "Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the…
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    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk

    Arrow International is recalling Pressure Injectable PICC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    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.
    Category
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow PICC Recall Initiated Due to Safety Cover Disengagement and Needlestick Injury

    Arrow International is recalling Arrow PICC products with Chlorag+ard Technology due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow VPS Access Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters…
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    Distribution
    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow International Recalls Two-Lumen Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific lots of two-lumen hemodialysis catheterization kits due to a Class II medical device recall.

    Product
    Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow VPS Access Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling VPS Access Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Access Kit Recalled Due to Needlestick Injury Risk

    Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the…
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    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Arterial Line Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling Arterial Line Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow Central Venous Catheter Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling 43,394 units of ARROWg+ard Blue PLUS Two-Lumen Central Venous Catheterization Kits due to safety cover disengagement and needlestick injury reports.

    Product
    ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Access Kits Due to Needlestick Injury Risk

    Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
    Category
    Distribution
    0 states