FDAFDA · Food and drugs·Recall number Z-1120-2018
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 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.
Published March 28, 2018 · Recall initiated: February 23, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Components, Inc dba MedComp
- Distributor
- 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.
- Lot
- Lot Numbers: MCBS820, MCBM670, MCDY280, MCDW670, MCFX 650, MCFW520, MCCC910, MCCJ210, MCDF970, MCCV540, MCFJ340, MCFQ090 & MCFS610.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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