MedComp Recalls Duo-Flow IJ Full Trays Due to Suture Wing Cracking
Medical Components, Inc. is recalling Duo-Flow IJ Full Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
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 risk of serious harm (bleeding, air emboli) but the source explicitly states that no serious injury or death has been reported, fitting the criteria for a High severity score.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling the Duo-Flow IJ Full Tray (models MCDLT114IJ, MCDLT116IJ, and MCDLT118IJ). The recall was initiated because the suture wings on these devices have the potential to crack or break. The products were distributed nationwide and worldwide.
The potential hazards associated with the malfunction include catheter dislocation, bleeding, and air emboli. The firm has received six complaints regarding malfunction, involving 29 broken suture wings. To date, there have been no reports of serious injury or death associated with these complaints.
Healthcare providers should stop using the affected devices and contact the manufacturer for further instructions. Consumers should check their inventory for the specific model numbers and lot codes listed in the official recall notice.
The recalled product
- Product
- Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
- 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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