MedComp recalls DUO FLOW Custom Trays with serial numbers 414, 415, and 67 due to risk of suture wings cracking, which could cause catheter dislocation, bleeding, or air emboli. Six complaints reported without serious injury.
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 specific DUO FLOW Custom Trays (serial numbers 414, :415, and 67) because their suture wings might crack. This could lead to catheter dislocation, bleeding, or air emboli in patients. The recall has received six complaints but no serious injuries or deaths.
The suture wings in these trays can crack or break during use, which might cause the catheter to become dislodged from the patient. This could result in bleeding or air emboli, where air enters the bloodstream.
Healthcare professionals using MedComp DUO FLOW Custom Trays for medical procedures are most at risk. Patients using these trays during surgery may experience complications if the suture wings crack.
Check for DUO FLOW Custom Trays with serial numbers 414, 415, or 67. These trays were sold with specific medical device codes like MCBC900, MCBP350, and others listed in the recall notice.
Identify if your tray has serial numbers 414, 415, or 67.
No serious injuries or deaths have been reported, though six complaints of broken suture wings were received.
The recall does not specify a remedy, so contact MedComp directly for guidance.
Check for serial numbers 414, 415, or 67 on the tray, as these specific models were recalled.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-2941-2018 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2941-2018 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.