Reported Sep 10, 2014 · Terminated
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage:…
Galt Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
- GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX
- ONLY UNITS 1 STERILE EO Product UsageUsed in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature
- Lot codes and dates
- Catalot Numbers
KIT-043-06KIT-043-07KIT-043-08KIT-043-09KIT-043-10KIT-043-11KIT-053-06KIT-053-07KIT-053-08KIT-053-09KIT-053-10KIT-053-11KIT-053-12KIT-053-17KIT-053-18KIT-053-19KIT-053-20KIT-053-21and KIT-053-22
- Catalot Numbers
- Amount recalled
- 11,155 units in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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