FDA-Device2014-09-10Class II
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.
Galt Medical Corporation
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.
Sold states
Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
Affected count
11,155 units in total
Manufactured in
2220 Merritt Dr, Garland, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2014Don't want to check this manually?
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