FDAJuly 16, 2019device

Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable device...

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

The hazard

There was incorrect raw material used in the production of the identified lot.

What to do

FDA enforcement status: Terminated

Brands named

tedan surgical innovationstedantedan surgical

Recall history

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

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Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable device... — Recall Details · AllClear