Home / Recalls / Medical Components, Inc dba MedComp / Z-2936-2018

Z-2936-2018 Class II Terminated

Recalled by Medical Components, Inc dba MedComp — Harleysville, PA

Recall Details

Product Type
Devices
Report Date
September 5, 2018
Initiation Date
July 12, 2018
Termination Date
July 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits

Reason for Recall

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.

Distribution Pattern

Nationwide distribution; worldwide distribution.

Code Information

MKAZ210 MCBK870 MCBS910 MCBZ450 MCCP990 MCCZ440 MCDNlOO MCDQ930 MCFD710 MCFN970 MCFS730 MCAS340 MCBA830 MCBR880 MCBY910 MCCF130 MCCX150 MCDF010 MCDG980 MCDP120 MCFD720 MCFJ060 MCFM520 MCFW300 MCFZ590 MKAJ380 MCAS230 MCBL150 MCBN500 MCBZ380 MCCV010 MCDF030 MCFX080 MCFV620 MCBA170 MCDC940 MKAX240 MCAC870 MCCQ000 MCFG380 MKAQ920 MCAH920 MCCW950

Other recalls by Medical Components, Inc dba MedComp

  • Z-1184-2021 Class II — Power Injectable CT Port insertion kits - Product Usage: is an implantable acces (January 13, 2021)
  • Z-2940-2020 Class II — Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 (July 27, 2020)
  • Z-1149-2019 Class II — 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC (March 13, 2019)
  • Z-2215-2019 Class II — 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item (March 13, 2019)
  • Z-2216-2019 Class II — 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item (March 13, 2019)
  • Z-2217-2019 Class II — 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item (March 13, 2019)
  • Z-0222-2020 Class II — C3 Wave App, v. 2.0.5 (October 1, 2018)
  • Z-2942-2018 Class II — DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOU (July 12, 2018)
  • Z-2939-2018 Class II — SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424 (July 12, 2018)
  • Z-2937-2018 Class II — Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 (July 12, 2018)