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.
Z-1845-2020
Product summary
- Event
- Event 85360
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1845-2020
Official wording
Reason: There was incorrect raw material used in the production of the identified lot.
Code information: Lot: 0619
Distribution pattern: US Nationwide distribution in the states of NJ.
Derived failure modes
-
Unknown
There was incorrect raw material used in the production of the identified lot.