FDA recall Z-1127-2018

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2018