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.

51–56 of 56

  • 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 nationwide due to reports of safety cover disengagement and needlestick injuries.

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

    Arrow International Recalls Hemodialysis Catheter Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 hemodialysis catheterization kits nationwide because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk

    Arrow International is recalling Pressure Injectable PICC Kits because the packaged BD Eclipse Needle has a safety cover that 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
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk

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

    Product
    QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit 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 CVC Kits Due to Needlestick Injury Risk

    Arrow International is recalling ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits because packaged BD Eclipse Needles 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 ma be inserted into the jugular, subclavian or femoral veins
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-06-14

    Arrow Catheter Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling catheterization kits because the packaged BD Eclipse Needle has a safety cover that can disengage, causing needlestick injuries.

    Product
    Pressure Injectable Multi-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)…
    Category
    Distribution
    0 states