Medical Components, Inc dba MedComp recalls 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated fo…

Recall date

February 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1123-2018

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

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, Irelan…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 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.