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U.S. Department of Health and Human Services

Class 2 Device Recall Langston Dual Lumen Catheters

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  Class 2 Device Recall Langston Dual Lumen Catheters see related information
Date Initiated by Firm September 02, 2010
Date Posted September 28, 2010
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-2608-2010
Recall Event ID 56709
510(K)Number K051395  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length,
Usage: Indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites, This type of pressure measurement is useful in determining transvalvular, intravascular and interventricular pressure gradients.
Code Information Lot 548110, 548227, 548364, 548430, 548554, and 548723.
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6464 Sycamore Ct
Maple Grove MN 55369-6032
For Additional Information Contact
763-656-4300
Manufacturer Reason
for Recall		 Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk of product contamination. It is possib
FDA Determined
Cause 2		 Process control
Action Consignees were sent on 9/2/10, a Vascular Solutions "Urgent Medical Device Field Action" letter dated September 1, 2010. The letter was addressed to Cath Lab Manager. The letter descried the product and the problem. Provided instructions to examine pouches of opened boxes to see if they have not been sealed. If unsealed, they recommended to remove pouches from the current inventory. For unopened boxes they recommended to remove the boxes from the inventory. Requested consignees to complete the Field Action Customer Inventory Form included with the letter. For any questions, please contact the firm at 763-656-6032.
Quantity in Commerce 1,128 boxes ( 5pk)
Distribution AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS,MO, NE, NY,NH, NJ, NM, NY,NC, OH, OK, OR, A, PR, SC, TN, TX, UT, VA, WA, WV, WI, and WY. SINGAPORE, MEXICO, CANADA, SPAIN, AUSTRIA, GERMANY, ITALY, ENGLAND, and SWITZERLAND.
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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