FDA-Device2020-05-13Class II
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.
TeDan Surgical Innovations LLC
Hazard
There was incorrect raw material used in the production of the identified lot.
Sold states
US Nationwide distribution in the states of NJ.
Affected count
2 units
Manufactured in
12615 W Airport Blvd Ste 200, N/A, Sugar Land, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2020Don't want to check this manually?
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