Home / Recalls / Medical Components, Inc dba MedComp / Z-2932-2018

Z-2932-2018 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 XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108

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

MCAW430, MCBR560, MCCX620 MCCF020 MCFK440 MKAY620

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-2936-2018 Class II — Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialy (July 12, 2018)
  • Z-2937-2018 Class II — Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 (July 12, 2018)