FDAFebruary 23, 2018device

12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 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.

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

medical components inc dba medcompmedicalmedical components

UPCs

884908027266

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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