Galt Medical Corporation: Medical Device Recall in 2014 - (Recall #: Z-2589-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 25, 2014

Date Posted: September 10, 2014

Recall Number: Z-2589-2014

Event ID: 68939

Reason for Recall:

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

Status: Terminated

Product Quantity: 11,155 units in total

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.

Voluntary or Mandated:

Voluntary: Firm initiated