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U.S. Department of Health and Human Services

Class 2 Device Recall none

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  Class 2 Device Recall none see related information
Date Initiated by Firm February 08, 2010
Date Posted May 11, 2010
Recall Status1 Terminated 3 on March 21, 2011
Recall Number Z-1592-2010
Recall Event ID 54680
510(K)Number K000737  
Product Classification Vessel Dilator for Percutaneous Catheterization - Product Code DRE
Product Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.
Code Information Lot F0620209
Recalling Firm/
Manufacturer		 Galt Medical Corp
2220 Merritt Dr
Garland TX 75041-6137
For Additional Information Contact
972-271-5177
Manufacturer Reason
for Recall		 Potential problem with pouch seal thus affecting sterile product.
FDA Determined
Cause 2		 Packaging process control
Action Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.
Quantity in Commerce 400 units
Distribution Nationwide Distribution -- MI, PA, IL, & Washington, D.C.
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 = DRE and Original Applicant = XENTEK MEDICAL, INC.
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