Duo-Flow Double Lumen Catheter Only/Catheter Set
Medical device recall Z-2938-2018. Published in FDA’s Enforcement Report on Sep 5, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 5, 2018. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 791 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide distribution; worldwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 12, 2018.
- FDA classified it on Aug 25, 2018.
- FDA’s Enforcement Report published it on Sep 5, 2018.
- FDA terminated it on Jul 2, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medical Components, Inc dba MedComp, of Harleysville, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.