Soft-Line Ij Double Lumen Catheter 11.5Fr X 12cm, Soft-Line Ij Double Lumen Catheter 11.5Fr X 15cm, Soft-Line Lumen Cath

• 11 recalls, same reason

  • Terminated Z-2942-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2937-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2935-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2941-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2940-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2936-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2939-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2933-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2934-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2938-2018 FDA Class II ·initiated 12 Jul 2018
  • Terminated Z-2932-2018 FDA Class II ·initiated 12 Jul 2018

  The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

510(k) Number

K983511 ↗

FDA Product Code

MPB

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

Manufacturer's product page: Duo-Flow® Soft-Line®

• Duo Flow Catheter-Mc 54

  Class II

  FDA 510(k) K842416 Active Cleared 26 Jul 1984

• MCSCP8PS with 'y' Hub

  Class II

  FDA 510(k) K821684 Active Cleared 24 Jun 1982

• Twin Silicone Catheter

  Class II

  FDA 510(k) K923691 Active Cleared 25 Sep 1995

• Medicomp Flexi-Smooth Wound Drainage Catheter

  Class I

  FDA 510(k) K960426 Active Cleared 21 Mar 1996

• 1.9F X 20cm Vascu-Picc 1.9F X 50cm Vascu-Picc

  Class II

  FDA 510(k) K120980 Active Cleared 2 May 2012

• Double Lumen Sublcavian-Femoral

  Class II

  FDA 510(k) K841530 Active Cleared 25 Jun 1984

See all devices from Medical Components, Inc. →