Home / Recalls / Vascular Solutions, Inc. / Z-2249-2018

Z-2249-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
June 27, 2018
Initiation Date
May 4, 2018
Termination Date
October 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
276 units

Product Description

Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

Reason for Recall

The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.

Distribution Pattern

US Nationwide Distribution

Code Information

a) REF 8810, 5F x 9cm, Lot Numbers: 18037128, 18057123 (b) REF 8811, 6F x 9cm, Lot Numbers: 18026062, 18026063 (c) REF 8812, 5F x 15cm, Lot Number: 18050076

Other recalls by Vascular Solutions, Inc.

  • Z-0113-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • 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-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-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)