Device product
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.
Z-0533-2018
Product summary
- Event
- Event 78221
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-0533-2018
Official wording
Reason: 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.
Code information: Lot # MHGB030 Exp. Date 2020-07-30
Distribution pattern: Arabia, Australia, Israel, Brunei & Jamaica
Derived failure modes
-
Unknown
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.