FDA Device recall Z-2589-2014
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex
- FDA Device
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex by Galt Medical, citing the adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2589-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-25 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Galt Medical |
| Distribution | US |
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.
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.
Identifiers
| code_info | 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-05…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2589-2014%22
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