Z-0533-2018 Class II Terminated
FDA device recall Z-0533-2018 was initiated by Medical Components, Inc dba MedComp on May 25, 2017 and is designated Class II. 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. The recall status is terminated (terminated September 4, 2018). Affected quantity: 65 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- May 25, 2017
- Termination Date
- September 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 units
Product 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.
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 Pattern
Arabia, Australia, Israel, Brunei & Jamaica
Code Information
Lot # MHGB030 Exp. Date 2020-07-30