CLASS II Device recall · Reported 10 Sep 2014 · FDA Enforcement Report
Galt Valved Tearaway Kit Galt Vti w/ Sideport Stainless recalled
Galt Medical is recalling Galt Valved Tearaway Kit Galt Vti w/ Sideport Stainless Steel Dbl Flex, distributed nationwide in the US. The recall was initiated on 25 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2589-2014
- FDA event ID
- 68939
- Recalling firm
- Galt Medical, Garland, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2014
- FDA classified
- 4 Sep 2014
- Reported
- 10 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 25 Jul 2014 | Recall initiated by company | |
| 4 Sep 2014 | Classified by FDA | +41 days |
| 10 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
Questions about this recall
Why was it recalled?
The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 68939This product is part of a recall event; the main page for the event is Galt Valved Tearaway Introducer Set Galt Vti recalled by Galt Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Galt Valved Tearaway Introducer Set Galt Vti recalled by Galt Medical | Galt Medical | Other | Nationwide |
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