| Class 1 Device Recall Langston Dual Lumen Catheter | |
Date Initiated by Firm | March 16, 2020 |
Date Posted | April 27, 2020 |
Recall Status1 |
Terminated 3 on June 18, 2024 |
Recall Number | Z-1747-2020 |
Recall Event ID |
85350 |
510(K)Number | K051395 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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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
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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 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 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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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