# FDA recall Z-1184-2021

> **Medical Components, Inc dba MedComp** · Class II · device recall initiated 2021-01-13.

## Product

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

## Reason for recall

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.

## Distribution

US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021

## Key facts

- **Recall number:** Z-1184-2021
- **Recalling firm:** Medical Components, Inc dba MedComp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-13
- **Report date:** 2021-03-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Harleysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1184-2021

## Citation

> AI Analytics. FDA recall Z-1184-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1184-2021. Source: US FDA. Licensed CC0.

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