Medical Components, Inc dba MedComp

FDA Regulatory Profile

Summary

Total Recalls
38
510(k) Clearances
0
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1184-2021Class IIPower Injectable CT Port insertion kits - Product Usage: is an implantable access device designed toJanuary 13, 2021
Z-2940-2020Class IIMedcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024July 27, 2020
Z-1149-2019Class II14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422March 13, 2019
Z-2217-2019Class II14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 PrMarch 13, 2019
Z-2216-2019Class II14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 PrMarch 13, 2019
Z-2215-2019Class II14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 PrMarch 13, 2019
Z-0222-2020Class IIC3 Wave App, v. 2.0.5October 1, 2018
Z-2937-2018Class IIDuo-Flow XTP Straight Full Set, RMS02105 RMS02108July 12, 2018
Z-2932-2018Class IIDuo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108July 12, 2018
Z-2938-2018Class IIDuo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME July 12, 2018
Z-2934-2018Class IIDuo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kitJuly 12, 2018
Z-2939-2018Class IISOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424July 12, 2018
Z-2933-2018Class IIDouble Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/July 12, 2018
Z-2935-2018Class IIDuo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJJuly 12, 2018
Z-2940-2018Class IISOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98MJuly 12, 2018
Z-2936-2018Class IIDuo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertiJuly 12, 2018
Z-2941-2018Class IIDUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67July 12, 2018
Z-2942-2018Class IIDUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CJuly 12, 2018
Z-1122-2018Class II12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: TheFebruary 23, 2018
Z-1127-2018Class IIREPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for February 23, 2018