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Galt Medical Corporation recalls GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product
Recalled September 10, 2014 · FDA recall Z-2589-2014 · Galt Medical
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. · FDA Class II
Units
11,155 units in total
Sold at
Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
Description
The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
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.
Manufacturer(s)
Galt Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →