MedComp recalls 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits with a non-valved introducer instead of valved. 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 has recalled certain hemodialysis catheter insertion kits because they contain a non-valved introducer instead of the required valved one. Using these kits could lead to complications during dialysis treatments.
The kits are supposed to include a 15F valved introducer to prevent backflow during dialysis. However, the recalled kits contain a non-valved introducer, which could allow blood to flow backward and cause complications.
Patients receiving hemodialysis treatments who use these specific MedComp catheter insertion kits are affected. Healthcare providers who use the kits for dialysis procedures are most at risk.
Check for the product name '14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits' with item number MC061423. These kits were sold to healthcare facilities for dialysis procedures.
Look for the item number MC061423 on the kit packaging to confirm it is recalled.
The kits contain a non-valved introducer instead of the required valved one, which could lead to complications during dialysis procedures.
The recall record does not specify a remedy, so check the kit label for item number MC061423 and contact MedComp for further instructions.
The recall record does not mention a risk of serious injury, but using the incorrect introducer could lead to complications during dialysis.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-2215-2019 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2215-2019 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.