DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT
Medical device recall Z-2942-2018. 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, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet)
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MBZV810 MCFG890 MCAC560 MCBD000 MCBW980 MCCL620 MCCP130 MCDV260 MCDZ790 MCFP180 MCBQ850 MBZV880 MCAH760 MCAL150 MCAY870 MCBF510 MCBY350 MCCB930 MCCJ340 MCCN900 MCDD110 MCDV830 MCFA640 MCFK060 MCFT330 MKAB610 MKAH290 MKAN410 MHJY740 MHLD270…
Every code shown here, 2,000 characters
MBZV810 MCFG890 MCAC560 MCBD000 MCBW980 MCCL620 MCCP130 MCDV260 MCDZ790 MCFP180 MCBQ850 MBZV880 MCAH760 MCAL150 MCAY870 MCBF510 MCBY350 MCCB930 MCCJ340 MCCN900 MCDD110 MCDV830 MCFA640 MCFK060 MCFT330 MKAB610 MKAH290 MKAN410 MHJY740 MHLD270 MHMW060 MHMZ280 MHNS800 MHPT040 MHRY250 MHTY000 MHVK930 MHXA200 MHXK730 MJAX000 MJCH780 MCAJ250 MBZQ410 MBZV300 MBZV890 MCAM270 MCAT660 MCAT670 MCAT680 MCAW340 MCBF210 MCBG090 MCBG440 MCBN900 MCBP540 MCBZ560 MCCA880 MCCF140 MCCL210 MCCR210 MCDD770 MCDT410 MCDY970 MCFB780 MKAD710 MKAJ860 MKAM300 MKAT740 MKBA780 MBYZ570 MCAT370 MCBF000 MCDP270 MKAH580 MKAN420 MHNZ640 MHRN880 MHWY580 MJJL550 MLAX320 MLCT010 MCBF810 MCFL300 MHKF210 MHLP880 MHMT220 MHNL490 MHRD110 MHSR490 MHXA140 MHYR000 MJBK230 MBZX830 MCAX290 MCAY730 MCBF100 MCBG080 MCBQ930 MCBZ390 MCCQ320 MCDB560 MCDL600 MCDW870 MCFA580 MCFT970 MCFY800 MKAA090 MKAB620 MKAG540 MKAT120 MHJM830 MHJV270 MHSF270 MHVB060 MHXH670 MHZR140 MCAY880 MCBG910 MCBK800 MCBL750 MCCC150 MCCK660 MCDC490 MCDL620 MCDV520 MCDV990 MCFA590 MCFC020 MCFK070 MCFT480 MKAG550 MKAL420 MKAY970 MHJT340 MHKT600 MHLD280 MHMB120 MHMT230 MHMY750 MHPK450 MHQA360 MHRC850 MHRY260 MHSF280 MHSN360 MHSP790 MHVB070 MHVN940 MHWD770 MHWZ900 MHXB410 MHXD040 MHXG180 MHXK740 MHYH530 MHYQ620 MHYW780 MHZR170 MHZX910 MJAC390 MJAF850 MJAQ170 MJHR000 MJJL560 MHKT610 MCAX940 MCAY060 MBZT080 MBZX460 MCAB520 MCAJ690 MCAX720 MCBG170 MCBG420 MCCJ410 MCCW200 MCCX810 MCDD860 MCDY020 MCFG010 MCFH800 MCFK720 MCFQ290 MKAA530 MKAD270 MKAJ960 MKAP800 MKAS100 MKAY900 MKBA590 MCDW200 MCDW210 MCDW240 MCDW770 MCFH680 MBZV100 MBZV110 MBZW110 MBZX210 MCAM280 MCAM290 MCAM300 MCAT690 MCAT700 MCAT710 MCAT720 MCAT730 MCAX340 MCAX350 MCAX810 MCAY890 MCAY900 MCAZ660 MCAZ670 MCBA860 MCBB220 MCBC110 MCBC640 MCBC960 MCBD800 MCBF220 MCBF770 MCBG100 MCBM790 MCBN110 MCBP860 MCBP870 MCBY130 MCBY140 MCCA470 MCCB060 MCCB070 MCCC850 MCCD220 MCCD390 MCCF350 MCCF760 MCCH000 MCCH270 MCCH280 MCCJ090 MCCN170 MCCN180 MCCP770 MCCQ400 MCCX080 MCCX090 MCDA550 MCDC750 MCDC760…
FDA’s list runs to 5,679 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 5,679 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.