PlainRecalls
FDA Devices Moderate Class II Terminated

MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.

Reported: July 4, 2012 Initiated: April 2, 2012 #Z-1868-2012

Product Description

MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.

Reason for Recall

Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

Details

Units Affected
30
Distribution
Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
Location
Harleysville, PA

Frequently Asked Questions

What product was recalled?
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.. Recalled by Medical Components, Inc dba MedComp. Units affected: 30.
Why was this product recalled?
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 4, 2012. Severity: Moderate. Recall number: Z-1868-2012.