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.
- Recall Initiated
- May 25, 2017
- Terminated
- September 4, 2018
- Recall Number
- Z-0533-2018
- Quantity
- 65 units
- Firm Location
- Harleysville, PA
Reason for Recall
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.
Distribution
Arabia, Australia, Israel, Brunei & Jamaica
Lot / Code Info
Lot # MHGB030 Exp. Date 2020-07-30
Root Cause
Mixed-up of materials/components
Action Taken
On May 25, 2017, Medcomp distributed Product Recall notices to their customers via email. Medcomp requested the return of all un-used affected product. Customers were advised to immediately examine inventory and to quarantine product subject to recall. If product was further distributed, notification of the recall to those individuals is required. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The request can be made by telephone by calling 215-256-4201.