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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 Cathetersee related information
Date Initiated by FirmMarch 16, 2020
Date PostedApril 27, 2020
Recall Status1 Terminated 3 on June 18, 2024
Recall NumberZ-1747-2020
Recall Event ID 85350
510(K)NumberK051395 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductLangston 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 ContactPaul 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
ActionThe firm notified consignees that received affected product on March 26, 2020 via UPS Mail (US), email or mail (OUS). The firm s 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 Commerce30,877 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DQO
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