The Recall Desk

FDA (Devices) recall action 68939

Galt Medical Corporation recalled 2 products on 2014-09-10

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
2014-09-10
Critical
0
Units
22,310

Why these products were recalled

The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

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

  • HighFDA (Devices)··2014-09-10

    Galt Medical Recalls Valved Tearaway Kits Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Kits because the adhesive could dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-09-10

    Galt Medical Recalls Valved Tearaway Introducer Sets Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Introducer Sets because the adhesive may dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Distribution
    0 states