The Recall Desk
HighFDA (Devices)·Z-2934-2018·Announced 2018-09-05

MedComp Recalls Duo-Flow Hemodialysis Catheter Sets Due to Suture Wing Cracking

Medical Components, Inc dba MedComp is recalling Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets because suture wings may crack or break, posing a risk of patient injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect that poses a risk of harm (bleeding, air emboli), but the source explicitly states that no serious injury or death has been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Medical Components, Inc dba MedComp is voluntarily recalling the Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set, model DL11/24, and associated hemodialysis catheter insertion kits. The recall is due to a defect where the suture wings have the potential to crack or break.

The affected products were distributed nationwide and worldwide. The firm has received six complaints regarding malfunction, specifically noting 29 broken suture wings. The source text states that no serious injury or death has been reported to date.

Potential patient injuries associated with this defect include catheter dislocation, bleeding, and air emboli. Consumers and healthcare providers should stop using the affected products and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
Manufacturer
Medical Components, Inc dba MedComp
Category
Medical Device — Catheters
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • MCAL840 MCBB800 MCBW450 MCCH690

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Medical Components, Inc dba MedComp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same manufacturer · Medical Components, Inc dba MedComp

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Same hazard · structural failure

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