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U.S. Department of Health and Human Services

Class 1 Device Recall Langston Dual Lumen Catheter

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  Class 1 Device Recall Langston Dual Lumen Catheter see related information
Date Initiated by Firm March 16, 2020
Create Date April 27, 2020
Recall Status1 Open3, Classified
Recall Number Z-1747-2020
Recall Event ID 85350
510(K)Number K051395  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Code Information Model 5540; UDI 10841156100513; Lots 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 653443, 653565, 653776, 653863, 654010, 654190, 654340, 654514, 654657, 654889, 654890, 655128, 655287, 655460, 655465, 655738, 655869, 656191, 656533, 656554, 656727, 656801, 657030, 657243, 657517, 657627, 657680, 657866, 658018, 658151, 658250, 658438, 658541, 658671, 658824, 658984, 659122, 659217, 659362, 659443, 659630, 659855, 660075, 660199, 660288, 660397, 660590, 660717, 660823, 660910, 661139, 661257, 661474, 662824
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6420 Sycamore Ln N
Maple Grove MN 55369-6013
For Additional Information Contact Paul Campbell
763-762-2560
Manufacturer Reason
for Recall		 The inner lumen of the Langston catheter may separate from the hub during pressure injection.
FDA Determined
Cause 2		 Process control
Action The firm notified consignees that received affected product on March 26, 2020 via UPS Mail (US), email or mail (OUS). The firms immediate correction is to recall the affected devices for destruction. The notice includes instructions on subrecall for any consignees that further distributed affected product.
Quantity in Commerce 30,877 units
Distribution Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = VASCULAR SOLUTIONS, INC.
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