Z-2588-2014 Class II Terminated
FDA device recall Z-2588-2014 was initiated by Galt Medical Corporation on July 25, 2014 and is designated Class II. 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. The recall status is terminated (terminated February 26, 2016). Affected quantity: 11,155 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2014
- Initiation Date
- July 25, 2014
- Termination Date
- February 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,155 units in total
Product Description
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
Code Information
Catalog Numbers: NT-104-06, INT-104-07, INT-104-08, INT-104-09, INT-104-10, INT-104-11, INT-104-12, INT-104-17, INT-104-18, INT-104-19, INT-104-20, INT-104-21, INT-104-22, INT-104-23, INT-108-06, INT-108-07, INT-108-09, INT-108-10, INT-108-11, INT-108-12, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22, INT-108-22, VTI-002-06, VTI-002-07, VTI-002-08, VTI-002-09, VTI-002-09, VTI-002-10, VTI-002-11, VTI-002-12, VTI-002-17, VTI-002-18, VTI-002-19, VTI-002-20, VTI-002-21, VTI-002-22, VTI-002-23, VTI-003-06, VTI-003-07, VTI-003-08, VTI-003-09, VTI-003-10, VTI-003-11, VTI-003-12, VTI-003-17, VTI-003-18, VTI-003-19, VTI-003-20, VTI-003-21, VTI-003-22, and VTI-003-23.