FDAFDA · Food and drugs·Recall number Z-2589-2014
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.
Published September 10, 2014 · Recall initiated: July 25, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Galt Medical Corporation
- Distributor
- Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
- Lot
- Catalot Numbers: KIT-043-06, KIT-043-07, KIT-043-08, KIT-043-09, KIT-043-10, KIT-043-11, KIT-053-06, KIT-053-07, KIT-053-08, KIT-053-09, KIT-053-10, KIT-053-11, KIT-053-12, KIT-053-17, KIT-053-18, KIT-053-19, KIT-053-20, KIT-053-21, and KIT-053-22
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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