medical Class II Updated 2018-09-05

Medical Components, Inc dba MedComp recalls Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

Recalled Product

Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

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: MCBA810 MCBS660 MCAX580 MCBH13D MCBKOlO MCBN350 MCBY390 MCCV240 MCDA860 MCDG370 MCDJ730 MCDP710 MCFA850 MCFB360 MCFD630 MCFM700 MCFS710 MCFX790 MKAD790 MKAG470 MKAT090 MKAX630 MCBA820 MCBYS20 MCCP980 MCFD640 MCFQ350 MKAR100 MCAC610 MCAT590 MCCH750 MCDQ920 MCFV690 MCAH750 MCFZ550
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