MedComp Recalls Double Lumen CRRT Catheter Sets Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling specific hemodialysis catheter insertion kits because the 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 the source explicitly states that 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 Double Lumen CRRT/ABP Catheter Sets and Hemodialysis catheter insertion kits, specifically models DL 11/15, DL 11/20, and DL 9/15. The recall is due to a defect where the suture wings have the potential to crack or break.
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 these complaints.
The affected products were distributed nationwide and worldwide. Consumers and healthcare providers should stop using these specific catheter sets and contact the manufacturer for further instructions or replacements.
The recalled product
- Product
- Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
- 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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