9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable ...
FDA Device Recall #Z-1536-2017 — Class II — February 23, 2017
Recall Summary
| Recall Number | Z-1536-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 23, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medical Components, Inc dba MedComp |
| Location | Harleysville, PA |
| Product Type | Devices |
| Quantity | 71 units |
Product Description
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
Reason for Recall
The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
Distribution Pattern
Worldwide Distribution to PR and Panama
Lot / Code Information
MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
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.