Z-1845-2020 Class II Terminated
FDA device recall Z-1845-2020 was initiated by TeDan Surgical Innovations LLC on July 16, 2019 and is designated Class II. Reason for recall: There was incorrect raw material used in the production of the identified lot. The recall status is terminated (terminated September 14, 2021). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- July 16, 2019
- Termination Date
- September 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
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 Pattern
US Nationwide distribution in the states of NJ.
Code Information
Lot: 0619