Home / Recalls / Medical Components, Inc dba MedComp / Z-1149-2019

Z-1149-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
April 24, 2019
Initiation Date
March 13, 2019
Termination Date
March 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6830

Product Description

14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

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

Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

Code Information

MCAL680 MCBA840 MCBH140 MCBK600 MCBY920 MCCH670 MCCR320 MCCV590 MCDG930 MCDK980 MCDR400 MCFB320 MCFG490 MCFR460 MCFT410 MCFY850 MCFZ660 MKAD410 MKAN270 MKAP300 MKAT100 MKAX320 MKBA190 MKBK940 MKBL210 MKBP450 MKBV570 MMAA170 MMAD480 MMAS020

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-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-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)