medical Class II Updated 2021-03-17

Medical Components, Inc dba MedComp recalls Power Injectable CT Port insertion kits - Product Usage: is

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)
View official government recall

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