FDAFDA · Food and drugs·Recall number Z-1536-2017
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
Published March 29, 2017 · Recall initiated: February 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Components, Inc dba MedComp
- Distributor
- Worldwide Distribution to PR and Panama
- Lot
- MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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