MedComp Recalls Soft-Line Duo-Flow Double Lumen Catheter Trays
Medical Components, Inc dba MedComp is recalling Soft-Line Duo-Flow Double Lumen Catheter Trays 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 is classified as FDA Class II and involves a risk of serious harm (bleeding, air emboli) where no serious injury or death has yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medical Components, Inc dba MedComp is voluntarily recalling Soft-Line Duo-Flow Double Lumen Catheter Trays, including models T3500, T4000, T4400, and T4424. The recall is due to a defect where the suture wings have the potential to crack or break. The product was distributed nationwide and worldwide.
The FDA has classified this recall as Class II. The firm has received six complaints regarding malfunction, involving 29 broken suture wings. The potential patient injuries associated with this defect include catheter dislocation, bleeding, and air emboli. To date, no serious injuries or deaths have been reported in connection with this recall.
Healthcare facilities and consumers should stop using the affected catheter trays and contact the recalling firm for further instructions or a refund. The specific lot codes affected are listed in the official recall documentation.
The recalled product
- Product
- SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
- 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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