MedComp Recalls Soft-Line Duo-Flow Catheters Due to Suture Wing Cracking
Medical Components, Inc. is recalling Soft-Line Duo-Flow catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, or air emboli.
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 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 recalling Soft-Line Duo-Flow Double Lumen Catheters and Catheter Sets (models T94C, T94M, T96M, T98M). The recall is due to a defect where the suture wings have the potential to crack or break.
The company 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.
The affected products were distributed nationwide and worldwide. Consumers and healthcare providers should check their inventory for the specific model numbers and lot codes listed in the official recall notice and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Catheters
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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