Home / Recalls / Vascular Solutions, Inc. / Z-1747-2020

Z-1747-2020 Class I Terminated

Recalled by Vascular Solutions, Inc. — Maple Grove, MN

Recall Details

Product Type
Devices
Report Date
May 6, 2020
Initiation Date
March 16, 2020
Termination Date
June 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30,877 units

Product Description

Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

Reason for Recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Distribution Pattern

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.

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

Other recalls by Vascular Solutions, Inc.

  • Z-0112-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0110-2021 Class I — Langston Dual Lumen Catheter (August 31, 2020)
  • Z-0113-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0111-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-2249-2018 Class II — Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (May 4, 2018)
  • Z-2224-2017 Class I — Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Ca (April 25, 2017)
  • Z-2180-2017 Class II — Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. (April 12, 2017)
  • Z-1250-2017 Class II — GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Pr (January 12, 2017)
  • Z-0053-2017 Class I — Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. (September 16, 2016)
  • Z-0054-2017 Class I — Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized wi (September 16, 2016)