FDAJune 15, 2023device
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
What to do
FDA enforcement status: Ongoing
Brands named
megadyne medical productsmegadynemegadyne medical
UPCs
10614559105146106145591051531061455910516010614559103456
Recall history
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