The Recall Desk

FDA (Devices) recall action 82506

Arrow International Inc recalled 2 products on 2019-05-22

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-05-22
Critical
0
Units
1,926

Why these products were recalled

Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC

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.

1–2 of 2

  • ModerateFDA (Devices)··2019-05-22

    Arrow PICC Recall for Incorrect Length Labeling

    Arrow International Inc. is recalling Arrow PICC kits because some may contain a different length than labeled.

    Product
    Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure i
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-05-22

    Arrow PICC Recall for Incorrect Length Labeling

    Arrow International is recalling 963 Arrow PICC kits because some are labeled with the wrong length, potentially leading to incorrect clinical use.

    Product
    Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure i
    Category
    Distribution
    0 states