medical Class II Updated 2018-09-05

Medical Components, Inc dba MedComp recalls Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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