Device 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.
Z-2589-2014
Product summary
- Event
- Event 68939
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,155 units in total
- Official record key
device-enforcement:Z-2589-2014
Official wording
Reason: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Code information: 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
Distribution pattern: Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
Derived failure modes
-
Unknown
The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.