Home / Recalls / Medical Components, Inc dba MedComp / Z-2215-2019

Z-2215-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
March 13, 2019
Termination Date
March 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6830

Product Description

14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter

Reason for Recall

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Distribution Pattern

US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

Code Information

MCAK580 MCAS990 MCAY850 MCBA850 MCBH150 MCBN670 MCBY930 MCCC770 MCCK640 MCCN740 MCCR330 MCCW790 MCDC600 MCDK990 MCDR410 MCFB340 MCFG840 MCFL120 MCFP220 MCFT420 MCFZ280 MKAF340 MKAG480 MKAN280 MKAT110 MKAX330 MKBA730 MKBH920 MKBN710 MKBX790 MMAB370 MMAD450 MMAQ940

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-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-1149-2019 Class II — 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC (March 13, 2019)
  • Z-0222-2020 Class II — C3 Wave App, v. 2.0.5 (October 1, 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)
  • Z-2942-2018 Class II — DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOU (July 12, 2018)
  • Z-2941-2018 Class II — DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67 (July 12, 2018)