FDAJuly 5, 2017device

Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M, 12) TCNK-20-C, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) ...

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

The hazard

After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.

What to do

FDA enforcement status: Terminated

Brands named

cosman medicalcosman

Recall history

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

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