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.

1–25 of 56

  • 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 4 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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    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow International Recalls Hemodialysis Catheterization Kits

    Arrow International Inc. is recalling ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kits due to a Class II recall.

    Product
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions 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…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R)…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Arterial Catheterization Kits 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 with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
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    0 states
  • ModerateFDA (Devices)··2017-06-14

    Arrow International Recalls Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific hemodialysis catheterization kits due to a lack of clinical data supporting the antimicrobial surface's effectiveness in preventing infections.

    Product
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions 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…
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    0 states
  • 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 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter 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…
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    0 states
  • SevereFDA (Devices)··2017-06-14

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

    Arrow International is recalling 43,394 units of ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits nationwide due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.

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

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 units of MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R)…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow VPS Access Kit Recalled Due to Needlestick Injury Risk

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

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 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 which…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits due to safety cover disengagement and needlestick injury reports.

    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.
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    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk

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

    Product
    QuickFlash Radial Artery/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 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 Central Venous Access Kits Due to Needlestick Risk

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

    Product
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 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 jugular, subclavian, or femoral veins.…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls CVC Kits Due to Needlestick Injury Risk

    Arrow International is recalling specific CVC kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk to medical personnel.

    Product
    AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by…
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Central Venous Catheter Kits Recalled for Needlestick Injury 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 The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous…
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    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Injury Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse needles have a safety cover disengagement defect that poses a needlestick injury risk.

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

    Arrow International Recalls Multi-Lumen CVC Kits Due to Needlestick Risk

    Arrow International is recalling specific multi-lumen central venous catheter kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins
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    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Access Kits Due to Needlestick Injury Risk

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

    Product
    Arrow¿ Access Kit with Maximal Barrier Precautions 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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  • SevereFDA (Devices)··2017-06-14

    Arrow Central Venous Catheter Kits Recalled for Needlestick Injury Risk

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

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions…
    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 packaged BD Eclipse Needles 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
  • SevereFDA (Devices)··2017-06-14

    Arrow PICC Recall Due to Safety Cover Disengagement and Needlestick Risk

    Arrow International is recalling Arrow PICC devices with Chlorag+ard Technology because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling…
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    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

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

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) 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 including, but not…
    Category
    Distribution
    0 states
  • 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 may disengage, posing a needlestick injury risk.

    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…
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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 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 Hemostatis 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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    0 states
  • HighFDA (Devices)··2017-06-14

    Arrow PICC Kit Recall Due to Needlestick Injury Risk

    Arrow International is recalling specific 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