TeDan Surgical Innovations LLC recalls Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima…

Recall date

July 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1845-2020

FDA classification

Class II

Brand / firm

TeDan Surgical Innovations LLC

Sold / distributed

US Nationwide distribution in the states of NJ.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.