FDAFebruary 23, 2017device

9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are 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 nutriti...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.

What to do

FDA enforcement status: Terminated

Brands named

medical components inc dba medcompmedicalmedical components

UPCs

8849080312329

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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