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Recall Observatory FDA recall evidence

Device product

12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 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-1121-2018

February 23, 2018

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
Event
Event 79436
Status
Terminated
Classification
Class II
Quantity
55 kits
Official record key
device-enforcement:Z-1121-2018

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: MCCD870 I MCDK730 I MCDN640, MCCS670, MCDR570 & MCDS970.

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

    reason.no_named_rule · v1.0.0

    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.