MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking
Medical Components, Inc. is recalling hemodialysis catheter insertion kits 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 risk of serious harm (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 Catheter Full Tray hemodialysis catheter insertion kits. The affected products include models MCDLT3500, MCDLT4000, MCDLT4400, and MCDLT4424. These kits were distributed nationwide and worldwide.
The recall was initiated 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 this malfunction, involving 29 broken suture wings, but no serious injuries or deaths have been reported.
Consumers and healthcare facilities should stop using the affected hemodialysis catheter insertion kits and contact the manufacturer for instructions on how to return or dispose of the products.
The recalled product
- Product
- Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
- Manufacturer
- Medical Components, Inc dba MedComp
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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