# FDA recall Z-1127-2018

> **Medical Components, Inc dba MedComp** · Class II · device recall initiated 2018-02-23.

## Product

REPAIR KIT, REF RPK-01, UDI 884908039856    Product Usage:  The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.

## Reason for recall

There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

## Distribution

Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI.   International:   Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain  Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain  Sweden, Turkey & United Arab Emirates.

## Key facts

- **Recall number:** Z-1127-2018
- **Recalling firm:** Medical Components, Inc dba MedComp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-23
- **Report date:** 2018-03-28
- **Termination date:** 2020-01-10

- **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-1127-2018

## Citation

> AI Analytics. FDA recall Z-1127-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1127-2018. Source: US FDA. Licensed CC0.

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