Galt Valved Tearaway Introducer SET Galt VTI recall
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and…
Why was Galt Valved Tearaway Introducer SET Galt VTI 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Numbers: NT-104-06, INT-104-07, INT-104-08, INT-104-09, INT-104-10, INT-104-11, INT-104-12, INT-104-17, INT-104-18, INT-104-19, INT-104-20, INT-104-21, INT-104-22, INT-104-23, INT-108-06, INT-108-07, INT-108-09, INT-108-10, INT-108-11, INT-108-12, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22, INT-108-22, VTI-002-06, VTI-002-07, VTI-002-08, VTI-002-09, VTI-002-09, VTI-002-10, VTI-002-11, VTI-002-12, VTI-002-17, VTI-002-18, VTI-002-19, VTI-002-20, VTI-002-21, VTI-002-22, VTI-002-23, VTI-003-06, VTI-003-07, VTI-003-08, VTI-003-09, VTI-003-10, VTI-003-11, VTI-003-12, VTI-003-17, VTI-003-18, VTI-003-19, VTI-003-20, VTI-003-21, VTI-003-22, and VTI-003-23.
- Product
- GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and…
- Recalling firm
- Galt Medical Corporation
- Quantity
- 11,155 units in total
- Distribution
- Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
- Recall date
- September 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)