FDA-Device2017-03-29Class II
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
Medical Components, Inc dba MedComp
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.
Sold states
Worldwide Distribution to PR and Panama
Affected count
71 units
Manufactured in
1499 Delp Dr, Harleysville, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1536-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief