Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
FDA Device Recall #Z-2932-2018 — Class II — July 12, 2018
Recall Summary
| Recall Number | Z-2932-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 12, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medical Components, Inc dba MedComp |
| Location | Harleysville, PA |
| Product Type | Devices |
| Quantity | N/A |
Product Description
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Reason for Recall
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Distribution Pattern
Nationwide distribution; worldwide distribution.
Lot / Code Information
MCAW430, MCBR560, MCCX620 MCCF020 MCFK440 MKAY620
Other Recalls from Medical Components, Inc dba MedComp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1184-2021 | Class II | Power Injectable CT Port insertion kits - Produ... | Jan 13, 2021 |
| Z-2940-2020 | Class II | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 1... | Jul 27, 2020 |
| Z-2216-2019 | Class II | 14F x 24CM SLX Double Lumen Full Tray Hemodialy... | Mar 13, 2019 |
| Z-2215-2019 | Class II | 14F x 20CM SLX Double Lumen Full Tray Hemodialy... | Mar 13, 2019 |
| Z-2217-2019 | Class II | 14F x 30CM SLX Double Lumen Full Tray Hemodialy... | Mar 13, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.