6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: 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.
Enforcement
- Recall Number
- Z-0533-2018
- Event ID
- 78221
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medical Components, Inc dba MedComp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2018
- Initiation Date
- May 25, 2017
- Classification Date
- February 6, 2018
- Termination Date
- September 4, 2018
- Address
- 1499 Delp Dr, N/A, Harleysville, PA, 19438-2936, United States
Description
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: 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.
The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
Lot # MHGB030 Exp. Date 2020-07-30
Arabia, Australia, Israel, Brunei & Jamaica
65 units