Home / Recalls / Vascular Solutions, Inc. / Z-0112-2021

Z-0112-2021 Class I Terminated

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

Recall Details

Product Type
Devices
Report Date
October 28, 2020
Initiation Date
August 31, 2020
Termination Date
June 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,745 units

Product Description

Langston Dual Lumen Catheter.

Reason for Recall

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

Distribution Pattern

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

Code Information

Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503.

Other recalls by Vascular Solutions, Inc.

  • 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-1747-2020 Class I — Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in (March 16, 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)