MedComp recalls specific double lumen catheter sets due to potential suture wing cracking, which may 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 certain double lumen CRRT/ABP catheter sets and hemodialysis catheter insertion kits because their suture wings can crack or break. This could lead to catheter dislocation, bleeding, or air emboli in patients. The recall has received six complaints with no reported serious injuries.
The suture wings in the catheter sets 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.
Healthcare professionals using the recalled catheter sets for hemodialysis or CRRT treatments are most at risk. Patients receiving these procedures may experience complications if the catheter dislocates.
Check for the model numbers listed: MCAJ510, MCAP860, MCAZ820, MCCB890, MCCJ250, MCDF160, MCDQ630, MCFF200, MCFF620, MCFK200, MCFV440, MKAK310, MCAW770, MCBW430, MCCH320, MCCJ690, MCFB450, MCFF930, MCFV450, MKAK320, MKAV210, MCAY080, MCBD600, MCBP740, MCBW440, MCCA030, MCCH330. The products were sold under specific date codes: DL 11/15, DL 11/20, DL 9/15.
Identify the model number on the catheter set to see if it matches the listed models.
Reach out to MedComp directly for further assistance or to confirm if your product is affected.
No serious injuries or deaths have been reported as of the recall announcement.
The recall includes specific model numbers and date codes, but the exact number of units is not stated in the record.
The recall record 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-2933-2018 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-2933-2018 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.