medical Class II Updated 2018-09-05

Medical Components, Inc dba MedComp recalls Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114

Recalled Product

Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M

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: MHJV260 MHMJ380 MHRC840 MHXF770 MJAZ910 MJDV230 MJLF440 MLCT530 MCAH650 MCAQ240 MCAW220 MCBC440 MCCJ920 MCCP260 MCDC910 MCDG320 MCDL590 MCDW940 MCFA540 MCFG000 MCFM820 MCFR060 MCFV060 MKAA520 MKAL360 MKAN510 MKAQ280 MKAZ530 MCAA590 MCAD760 MCAK990 MCBM860 MCBQ500 MCCA150 MCCG660 MCDD810 MCDG250 MCDJ980 MCDP910 MCDV760 MKAD560 MKAL370 MKBC340 MBZS180 MCAH050 MCAL000 MCBM870 MCBT030 MCCG580 MCCP590 MCDD570 MCDR280 MCDX060 MCFQ250 MCFS300 MCFT650 MCFX880 MKAB600 MKAM870 MBZY670 MCCT820 MCFQ150 MKBB070 MJLP070 MLDH060 MHLM190 MHRX850 MHSY930 MHYG710 MJCV440 MBYR870 MBZM650 MCAH670 MCAJ630 MCAQ250 MCAQ870 MCBA060 MCBD890 MCBX380 MCDF830 MCDL020 MCDR290 MCDX070 MCFA570 MCFD860 MCFH790 MKAF320 MKAG530 MKAK390 MKAL400 MKAM880 MKBA670 MCCT830 MHLJ070 MHRD620 MHRX860 MJKJ070 MCBC830 MCFK400
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