The Recall Desk

FDA (Devices) recall action 77589

Arrow International Inc recalled 4 products on 2017-12-06

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-12-06
Critical
0
Units
—

Why these products were recalled

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

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

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2017-12-06

    Arrow PICC Kits Recalled for Potential Incorrect Sheath Size

    Arrow International is recalling specific PICC kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure…
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2017-12-06

    Arrow International Recalls Pressure Injectable PICC Kits Due to Sheath Error

    Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable PICC kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr sheaths.

    Product
    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast…
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2017-12-06

    Arrow VPS Access Kit Recalled for Potential Size Mismatch

    Arrow International is recalling VPS Access Kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    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…
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2017-12-06

    Arrow PICC Recall Due to Potential Incorrect Peel-Away Sheath Size

    Arrow International is recalling specific lots of ARROW PICC powered by ARROW VPS Stylet kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure…
    Category
    Distribution
    8 states