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U.S. Department of Health and Human Services

Class 2 Device Recall Galt Valved Tearaway Kit

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  Class 2 Device Recall Galt Valved Tearaway Kit see related information
Date Initiated by Firm July 25, 2014
Date Posted September 04, 2014
Recall Status1 Terminated 3 on February 26, 2016
Recall Number Z-2589-2014
Recall Event ID 68939
510(K)Number K112398  
Product Classification Introducer, catheter - Product Code DYB
Product 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.
Code Information 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
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 and Original Applicant = GALT MEDICAL
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