MedComp Duo-Flow XTP Straight Full Set Recalled for Suture Wing Cracking
Medical Components, Inc. is recalling Duo-Flow XTP Straight Full Sets 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 risk of serious harm (bleeding, air emboli) but the source explicitly states 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 the Duo-Flow XTP Straight Full Set, model numbers RMS02105 and RMS02108. The recall is due to a defect where the suture wings have the potential to crack or break.
The malfunction of the suture wings could lead to patient injury, including catheter dislocation, bleeding, and air emboli. The firm has received six complaints regarding malfunction, which involved 29 broken suture wings. No serious injuries or deaths have been reported to date.
The affected products were distributed nationwide and worldwide. Consumers and healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Surgical Suture
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- MKAC440 MCCH440
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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- High