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.
Reported: September 10, 2014 Initiated: July 25, 2014 #Z-2588-2014
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.
Details
- Recalling Firm
- Galt Medical Corporation
- Units Affected
- 11,155 units in total
- Distribution
- Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
- Location
- Garland, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Galt Medical Corporation. Units affected: 11,155 units in total.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Moderate. Recall number: Z-2588-2014.
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