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Use caution Medical device recall · FDA · Published February 23, 2018

MedComp 12F Tesio Catheter Set Recall: Risk of Blood Loss or Air Emboli

MedComp recalls 12F Tesio Catheter Set (REF MCTC1247SD) due to potential connection failures causing blood loss or air emboli. Affected units have specific lot numbers and UDI.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1124-2018Medical deviceMedComp ›
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Contact the company

Recalling firmMedical Components, Inc dba MedComp1499 Delp Dr · Harleysville, PA 19438-2936
✎ GovInfoNow plain-language explainer

MedComp is recalling 12F Tesio Catheter Sets that may cause blood loss or air emboli due to connection failures. This is serious for patients using hemodialysis equipment. Read more at govinfonow.com/recall/71877-medcomp-12f-tesio-catheter-set-recall-risk-of-blood-loss.

Source Summary by GovInfoNow · govinfonow.com/recall/71877-medcomp-12f-tesio-catheter-set-recall-risk-of-blood-loss · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1124-2018

Cite this page

“MedComp 12F Tesio Catheter Set Recall: Risk of Blood Loss or Air Emboli.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71877-medcomp-12f-tesio-catheter-set-recall-risk-of-blood-loss. Based on FDA recall #Z-1124-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1124-2018%22&limit=1).

The FDA announced on Feb. 23, 2018, that Medical Components Inc dba MedComp voluntarily recalled specific 12F Tesio catheter sets due to potential connection failures that may cause blood loss or air emboli. The agency issued recall number Z-1124-2018 for the Class II device.

How to tell if you have it

  • Brand: MedComp
  • Product: 12F Tesio CATHETER SET (CUFF 32CM FROM TIP)
  • REF: MCTC1247SD
  • UDI: 884908027266
  • Lot Numbers: MCBM830, MCDZ620 & MCDP130

The hazard

The recall cites the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines. Such failures may contribute to blood loss or air emboli.

Context

GovInfoNow's records show Medical Components Inc dba MedComp has 7 other recalls on record since Nov. 22, 2017. Other recent recalls of similar products include Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (Aug. 10, 2026), Merit Medical Systems CentrosFLO Hemodialysis Catheters Recall (Feb. 13, 2026) and Medline Medical Procedure Kits Recall (May 4, 2026).

How to tell if you have this one

Check for the product name '12F Tesio Catheter Set' with reference number MCTC1247SD. Affected units have lot numbers MCBM830, MCDZ620, or MCDP130 and UDI 884908027266.

  • Brand
    MedComp
  • Category
    Medical device
FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
Recall numberProduct, codes & lotsQuantity
Z-1118-2018CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCFW420, MCDD880, MCDN790, MCCK830, MCCV200, MCCX830, MCDB100, MCDT910 & MCFL210.93 kits
Z-1119-2018REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Number: MCFH0905 kits
Z-1120-201812F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCBS820, MCBM670, MCDY280, MCDW670, MCFX 650, MCFW520, MCCC910, MCCJ210, MCDF970, MCCV540, MCFJ340, MCFQ090 & MCFS610.712 kits
Z-1121-201812F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCCD870 I MCDK730 I MCDN640, MCCS670, MCDR570 & MCDS970.55 kits
Z-1122-201812F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCBP460, MCFJ310, MCDP870, MCFY580, MCFT400, MKAFOSO, MCDF810, MCDGllO, MCDG210, MCCW260, MCFJ310 & MCFQ070.385 kits
Z-1123-201812F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCBM830, MCDZ620 & MCDP130.40 kits
Z-1124-201812F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCBM830, MCDZ620 & MCDP130.N/A
Z-1125-2018TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCFF700, MCFB160, MKAG11O, MCDP590, MCDS140 & MCFSOSO35 kits
Z-1126-2018CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCBX400, MCFA150, MCFT460, MCCHOlO, MCDN490, MCCV190, MCCZ680, MCDDlOO, MCDV170, MCDW310315 kits
Z-1127-2018REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.; Lot Numbers: MCCC310, MCCA800, MCFH990, MCFC040, MCFA160, MKAB730, MCFW690 , MCFS390, MKAB730, MCCC310, MCCC320, MCCL340, MCDD250, MCDD640, MCDP460 , MCCL340, MCDDZSO, MCDP460, MCDVOSO , MCDV820, MCFN890 & MCFS930.1575 kits
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product name, reference number, lot numbers, and UDI code to confirm if your catheter set is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: nationwideAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Feb 23, 201812. FDA classified it Class II: Mar 19, 201823. Published in FDA’s Enforcement Report: Mar 28, 201834. FDA terminated the recall: Jan 10, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a repair kit available?

Yes, MedComp provides a repair kit for replacing damaged female connectors, clamps, or repairing extensions with at least 4.5cm of tubing.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1124-2018 (February 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1124-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA