Z-2589-2014Class II

GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO

Name: Z-2589-2014 GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO
Creator: Galt Medical Corporation
Published: 2014-07-25
License: https://open.fda.gov/license/

Galt Medical Corp / initiated 2014-07-25 / Terminated / root cause: manufacturing process

FDA source

Galt Medical Corporation began a recall of 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... on 2014-07-25. FDA classified it as Class II and gives the reason as "The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2589-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-25
Posted: 2014-09-04
Terminated: 2016-02-26
Recalling firm: Galt Medical Corp
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Galt Medical sent an Urgent Medical Device Recall letters to all affected customers. The letter identified the affected product, reason for recall and actions to be taken. Customers were asked to identify and segregate the recalled lot (s) that is in their possession, complete and return the enclosed Recall Reply form, and return the recalled product to Galt Medical Corp. For questions contact your local sales representative or Recall Coordinator at 214-778-1306.
Quantity in commerce: 11,155 units in total
Distribution: Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2589-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2588-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04
Z-2589-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04

Product code DYB

K112398Class IITriv(tm) Valved Tearaway Introducer, Tirv(tm) Valved Tearaway Introducer with Side PortGalt Medical / cleared 2012-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)