MedComp recalls Duo-Flow Catheter Full Tray kits for potential suture wing cracks causing catheter dislocation, bleeding, or air emboli. Six complaints reported with no serious injuries.
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.
MedComp is recalling Duo-Flow Catheter Full Tray kits because suture wings might crack or break, which could lead to catheter dislocation, bleeding, or air emboli. This recall follows six reported complaints of broken suture wings without serious injuries.
The suture wings in the catheter insertion kits can crack or break during use. If this happens, it may cause the catheter to become dislocated, leading to bleeding or air emboli in the patient's bloodstream.
Hemodialysis patients and healthcare providers using the Duo-Flow Catheter Full Tray kits. Those most at risk are users who have the specific model numbers listed in the recall.
Check for Duo-Flow Catheter Full Tray kits with model numbers including MCDLT3500, MCDLT4000, MCDLT4400, MCDLT4424, or other listed codes. These kits were sold for hemodialysis catheter insertion.
Identify the model number on the kit to see if it matches the recalled list (e.g., MCDLT3500, MCDLT4000).
The suture wings have the potential to crack or break, which could cause catheter dislocation, bleeding, or air emboli. Six complaints of broken suture wings were reported without serious injuries.
The recall record does not mention a remedy or fix. The manufacturer has not provided instructions for repair or replacement.
Check the model number on the kit. Recalled models include MCDLT3500, MCDLT4000, MCDLT4400, MCDLT4424, and other specific codes listed in the recall.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-2936-2018 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2936-2018 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.
