# FDA recall Z-0533-2018

> **Medical Components, Inc dba MedComp** · Class II · device recall initiated 2017-05-25.

## Product

6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157    Product Usage:  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 nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media.

## Reason for recall

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.

## Distribution

Arabia, Australia, Israel, Brunei & Jamaica

## Key facts

- **Recall number:** Z-0533-2018
- **Recalling firm:** Medical Components, Inc dba MedComp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-25
- **Report date:** 2018-02-14
- **Termination date:** 2018-09-04

- **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-0533-2018

## Citation

> AI Analytics. FDA recall Z-0533-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0533-2018. Source: US FDA. Licensed CC0.

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