Medcomp Gen III Power Injectable Port

Active United States Open recall

510(k) K132177

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK132177	Date12 Dec 2013Cleared	StatusActive

1 jurisdiction

United States — FDA 510(k) Active

4 recalls · 1 ongoing · FDA

- Ongoing Z-1184-2021 FDA Class II initiated 13 Jan 2021
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.
- Terminated Z-1271-2018 FDA Class II initiated 22 Nov 2017
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
- Terminated Z-0533-2018 FDA Class II initiated 25 May 2017
The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
- Terminated Z-1536-2017 FDA Class II initiated 23 Feb 2017
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.

510(k)