The Recall Desk

FDA (Devices) recall action 74898

Arrow International Inc recalled 4 products on 2016-09-21

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
2016-09-21
Critical
0
Units
24,484

Why these products were recalled

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2016-09-21

    Arrow Select Kit Recall Due to Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 Arrow Select Kit units due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-09-21

    Arrow International Recalls Select Kit Products Due to Molding Abnormality

    Arrow International is recalling 6,121 units of Select Kit products due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-09-21

    Arrow Single-Lumen Catheters Recalled for Packaging Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Single-Lumen Catheters due to a molding abnormality in the packaging component supplied by a vendor.

    Product
    Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2016-09-21

    Arrow Select Kit Ultrasound Catheters Recalled for Packaging Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Select Kit ultrasound catheters due to a component molding abnormality in the packaging.

    Product
    Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
    Category
    Distribution
    4 states