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TeDan Surgical Innovations LLC recalls Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima
Recalled May 13, 2020 · FDA recall Z-1845-2020 · TeDan Surgical Innovations
Hazard
There was incorrect raw material used in the production of the identified lot. · FDA Class II
Units
2 units
Sold at
US Nationwide distribution in the states of NJ.
Description
There was incorrect raw material used in the production of the identified lot.
Product
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 devices that are connected to the hospital suction system to remove debris and blood from the surgical field.
Manufacturer(s)
TeDan Surgical Innovations LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →