MedComp Duo-Flow Double Lumen Catheters Recalled for Suture Wing Cracking
Medical Components, Inc. is recalling Duo-Flow Double Lumen Catheters because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and 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 potential for serious patient injury (bleeding, air emboli) but no reported serious injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling specific lots of Duo-Flow Double Lumen Catheter Only/Catheter Sets. The recall involves multiple model numbers, including T114C, T114M, T116C, T116M, T116ME, T118C, T118M, T118ME, and T119M. The products were distributed nationwide and worldwide.
The recall is being issued because the suture wings on the catheters have the potential to crack or break. This malfunction could lead to patient injury, including catheter dislocation, bleeding, and air emboli. The firm has received six complaints regarding malfunction, involving 29 broken suture wings, but no serious injuries or deaths have been reported.
Healthcare facilities and consumers should stop using the affected catheters and contact Medical Components, Inc. for instructions on how to return or dispose of the products. The specific lot codes affected are listed in the official recall documentation.
The recalled product
- Product
- Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
- 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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