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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
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