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U.S. Department of Health and Human Services

Class 1 Device Recall Langston Dual Lumen Catheters

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  Class 1 Device Recall Langston Dual Lumen Catheters see related information
Date Initiated by Firm May 27, 2014
Date Posted July 03, 2014
Recall Status1 Terminated 3 on January 30, 2015
Recall Number Z-1981-2014
Recall Event ID 68489
510(K)Number K051395  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
Code Information Lot Numbers: 569436, 569437, 569962

569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415, and 571727.
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove MN 55369-6032
For Additional Information Contact Customer Service
763-656-4300
Manufacturer Reason
for Recall		 The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
FDA Determined
Cause 2		 Component design/selection
Action Vascular Solutions sent an Urgent Medical Device Removal letter dated May 23, 2014, to all affected consignees.The letter described the problem and the product affected by the recall. Advised consignees to remove affected devices and place them in a secure area. Requested consignees to fill and return the "VSI Account Inventory Form" to VSI's Customer Service Department by email customerservice@vasc.com or fax 763-656-4251. VSI will replace all returned devices. Customers with questions were advised to contact their local Vascular Solutions Account Manager. For questions regarding this recall call 763-656-4300.
Quantity in Commerce 8,580 total (US 5714)
Distribution Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
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 = DQO and Original Applicant = VASCULAR SOLUTIONS, INC.
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