MedComp recalls Duo-Flow XTP Straight Full Sets (RMS02105, RMS02108) 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 XTP Straight Full Sets (RMS02105 and RMS02108) because suture wings might crack, leading to potential patient injuries like catheter dislocation, bleeding, or air emboli. The recall follows six reported complaints with no serious injuries.
Suture wings in the Duo-Flow XTP Straight Full Sets can crack or break, which might cause the catheter to dislocate from the patient. This could lead to bleeding or air emboli, where air enters the bloodstream.
Patients using these medical devices are most at risk if suture wings crack. Healthcare providers who use the Duo-Flow XTP Straight Full Sets may also be affected.
Check for Duo-Flow XTP Straight Full Sets with model numbers RMS02105 or RMS02108. These were sold under the brand names MKAC440 and MCCH440.
Inspect the suture wings for cracks or breaks, as this indicates a potential issue with the device.
No serious injuries or deaths have been reported in the six complaints received by MedComp.
The affected models are RMS02105 and RMS02108.
Look for Duo-Flow XTP Straight Full Sets with model numbers RMS02105 or RMS02108, which were sold under the brand names MKAC440 and MCCH440.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-2937-2018 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2937-2018 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.