MedComp recalls SOFT-LINE DUO-FLOW double lumen catheter trays (T3500, T4000, T4400, T4424) due to risk of suture wings cracking, which could cause 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 its SOFT-LINE DUO-FLOW double lumen catheter trays (models T3500, T4000, T4400, T4424) because suture wings may crack, potentially causing catheter dislocation, bleeding, or air emboli. This recall follows six reported complaints with no serious injuries or deaths.
The suture wings in these catheter trays can crack or break during use. If this happens, it may cause the catheter to dislocate, leading to bleeding or air emboli (air bubbles in the bloodstream).
Healthcare professionals using these catheter trays in medical settings are most at risk. Patients receiving procedures involving these trays could be affected if the suture wings crack.
Check for catheter trays with model numbers T3500, T4000, T4400, or T4424 from MedComp. These were sold with specific serial codes listed in the recall notice.
Inspect the tray for any cracks or breaks in the suture wings, which could indicate a malfunction.
Reach out to MedComp directly to confirm if your specific model is affected and to get instructions for next steps.
No serious injuries or deaths have been reported as of the recall announcement, though six complaints of broken suture wings were received.
Check for cracked suture wings and contact MedComp to determine if your model is affected and what steps to take next.
Yes, the affected models are T3500, T4000, T4400, and T4424.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-2939-2018 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2939-2018 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.
