| Class 2 Device Recall Galt VTI | |
Date Initiated by Firm | July 25, 2014 |
Date Posted | September 04, 2014 |
Recall Status1 |
Terminated 3 on February 26, 2016 |
Recall Number | Z-2588-2014 |
Recall Event ID |
68939 |
510(K)Number | K112398 |
Product Classification |
Introducer, catheter - Product Code DYB
|
Product | 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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Galt Medical Corporation 2220 Merritt Dr Garland TX 75041-6137
|
For Additional Information Contact | David Derrick 214-778-1306 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = DYB
|
|
|
|