MedComp recalls 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits (Item MC061425) due to containing non-valved introducers instead of valved ones. This could lead to complications during dialysis procedures.
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
MedComp is recalling 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits because they contain non-valved introducers instead of the required valved ones. This mismatch could cause complications during dialysis treatments if used incorrectly.
The kits are supposed to include a 15F "valved" peelable introducer, but they contain a 15F "non-valved" peelable introducer. Valved introducers prevent blood from flowing back into the catheter during insertion, which is critical for safe dialysis procedures. Non-valved introducers could lead to complications like bleeding or infection.
Hemodialysis patients and healthcare providers who use the recalled MedComp 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits (Item MC061425) are affected. Patients with kidney failure requiring dialysis are most at risk.
Check for the product name: 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits. The item number is MC061425. These kits were sold with specific medical device codes like MCAM240, MCBL480, and others.
Identify the item number (MC061425) and product name to confirm if your kit is recalled.
The recall is happening because the kits contain non-valved introducers instead of the required valved ones, which could lead to complications during dialysis procedures.
The official recall notice does not specify a remedy or action steps beyond checking product details. Contact MedComp directly for further guidance.
The recall indicates a potential risk of complications during dialysis due to the non-valved introducer, but the official notice does not specify the severity of risks.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-2217-2019 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2217-2019 from MedComp. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
