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Lower risk Medical device recall · FDA · Published March 13, 2019

MedComp 14F SLX Catheter Kits Have Wrong Introducer Type - Recall

MedComp recalls 14F SLX Double Lumen Hemodialysis catheter kits that contain non-valved introducers instead of valved ones, which could cause complications during dialysis.

🇺🇸 FDA recall #Z-1149-2019Medical deviceMedComp ›
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Recalling firmMedical Components, Inc dba MedComp1499 Delp Dr · Harleysville, PA 19438-2936
✎ GovInfoNow plain-language explainer

MedComp is recalling 14F SL: Double Lumen Full Tray Hemodialysis catheter insertion kits that contain non-valved introducers instead of valved ones. This mismatch could lead to complications during dialysis treatments. Read more at govinfonow.com/recall/68841-medcomp-14f-slx-catheter-kits-have-wrong-introducer-type-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/68841-medcomp-14f-slx-catheter-kits-have-wrong-introducer-type-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1149-2019

Cite this page

“MedComp 14F SLX Catheter Kits Have Wrong Introducer Type - Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68841-medcomp-14f-slx-catheter-kits-have-wrong-introducer-type-recall. Based on FDA recall #Z-1149-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1149-2019%22&limit=1).

The FDA announced on March 13, 2019, that Medical Components, Inc dba MedComp voluntarily recalled 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits due to a labeling error. The hazard involves the incorrect introducer type being included in the kits.

How to tell if you have it

  • Brand: MedComp
  • Product: 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits
  • Item No.: MC061422
  • Other Item Nos.: MCAL680, MCBA840, MCBH140, MCBK600, MCBY920, MCCH670, MCCR320, MCCV590, MCDG930, MCDK980, MCDR400, MCFB320, MCFG490, MCFR460, MCFT410, MCFY850, MCFZ660, MKAD410, MKAN270, MKAP300, MKAT100, MKAX320, MKBA190, MKBK940, MKBL210, MKBP450, MKBV570, MMAA170, MMAD480, MMAS020
  • Units affected: 6830

The hazard

According to the FDA, the tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Context

GovInfoNow's records show Medical Components, Inc dba MedComp has 7 other recalls on record since November 22, 2017. Other recent recalls of similar products include MedComp 15.SF X 24CM Titan HD Catheter Recall (July 27, 2020) and MedComp Power Injectable CT Port Kits Recalled (January 13, 2021). Additional similar product recalls include Medline Intubation Tray Recall (December 24, 2025) and Medline Medical Procedure Kits Recall (May 4, 2026).

How to tell if you have this one

Check for the item number MC061422 on the kit packaging. The kits were sold with specific model codes like MCAL680, MCBA840, and others listed in the recall notice.

  • Brand
    MedComp
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Packaging

    Look for the item number MC061422 on the kit packaging to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed in 20 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia.

Recall timeline

FDA terminated this recall 5 years after the firm started it.

1. Firm started the recall: Mar 13, 201912. FDA classified it Class II: Apr 16, 201923. Published in FDA’s Enforcement Report: Apr 24, 201934. FDA terminated the recall: Mar 5, 2024420192024
  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.

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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-1149-2019 (March 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1149-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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