FDA recall Z-1845-2020

TeDan Surgical Innovations LLC · Class II · device

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.

Reason for recall

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

Distribution

US Nationwide distribution in the states of NJ.

Key facts

Status
Terminated
Initiation date
2019-07-16
Report date
2020-05-13
Termination date
2021-09-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2020