MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking Risk
Medical Components, Inc. is recalling specific hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.
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 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 hemodialysis catheter insertion kits (catalog numbers AAC02106, AAC02107, and AAC02108). The recall was initiated because the suture wings on these devices have the potential to crack or break.
The company has received six complaints regarding malfunction, involving 29 broken suture wings. The source text states that no serious injury or death has been reported to date. However, the potential for patient injury includes catheter dislocation, bleeding, and air emboli.
The affected products were distributed nationwide and worldwide. Consumers and healthcare providers should stop using these specific kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
- Manufacturer
- Medical Components, Inc dba MedComp
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 (3)
- MCAW430
- MCBR560
- MCCX620 MCCF020 MCFK440 MKAY620
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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