FDAClass IIJuly 4, 2012

MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low recall

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

Why was MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015

Product
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable…
Recalling firm
Medical Components, Inc dba MedComp
Quantity
30
Distribution
Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
Recall date
July 4, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls