FDAJanuary 13, 2021device

Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

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

The hazard

The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.

What to do

FDA enforcement status: Ongoing

Brands named

medical components inc dba medcompmedicalmedical components

UPCs

884908149753

Recall history

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

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Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system. — Recall Details · AllClear