CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report

Duo-Flow Double Lumen Catheter Only/Catheter Set recalled

Medical Components is recalling Duo-Flow Double Lumen Catheter Only/Catheter Set, distributed nationwide in the US. The recall was initiated on 12 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMHJV260 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

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2938-2018
FDA event ID: 80581
Recalling firm: Medical Components, Harleysville, PA
Classification: Class II
Status: Terminated
Recall initiated: 12 Jul 2018
FDA classified: 25 Aug 2018
Reported: 5 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

12 Jul 2018	Recall initiated by company
25 Aug 2018	Classified by FDA	+44 days
5 Sep 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide distribution; worldwide distribution.

Nationwide

Questions about this recall

Is Duo-Flow Double Lumen Catheter Only/Catheter Set recalled?

Yes. Medical Components recalled Duo-Flow Double Lumen Catheter Only/Catheter Set on 12 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-2938-2018.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationwide distribution; worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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