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.