MedComp recalls Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets 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 Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets because suture wings may crack, leading to potential patient injury like catheter dislocation, bleeding, or air emboli. Six complaints have been reported with no serious injuries or deaths.
Suture wings on the catheter set can crack or break during use. If this happens, it may cause the catheter to dislocate, leading to bleeding or air emboli in the patient's bloodstream.
Healthcare professionals using hemodialysis catheter insertion kits for patients. Patients receiving treatment with these catheters are at risk if the suture wings crack.
Check for Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets with model numbers DL11/24. These kits were sold under manufacturer codes MCAL840, MCBB800, MCBW450, and MCCH690.
Look for model numbers DL11/24 on the catheter set packaging or label.
No serious injuries or deaths have been reported as of the recall announcement.
The recall includes catheter sets with six reported complaints of broken suture wings.
The recall does not specify a remedy, so contact MedComp directly for guidance.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-2934-2018 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2934-2018 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.