Device product
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.
Z-1120-2018
Product summary
- Event
- Event 79436
- Status
- Terminated
- Classification
- Class II
- Quantity
- 712 kits
- Official record key
device-enforcement:Z-1120-2018
Official wording
Reason: 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.
Code information: Lot Numbers: MCBS820, MCBM670, MCDY280, MCDW670, MCFX 650, MCFW520, MCCC910, MCCJ210, MCDF970, MCCV540, MCFJ340, MCFQ090 & MCFS610.
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.
Derived failure modes
-
Unknown
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.