Z-1127-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- February 23, 2018
- Termination Date
- January 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1575 kits
Product Description
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 Pattern
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.
Code Information
Lot Numbers: MCCC310, MCCA800, MCFH990, MCFC040, MCFA160, MKAB730, MCFW690 , MCFS390, MKAB730, MCCC310, MCCC320, MCCL340, MCDD250, MCDD640, MCDP460 , MCCL340, MCDDZSO, MCDP460, MCDVOSO , MCDV820, MCFN890 & MCFS930.